Unsafe Safety Systems: SSRIs and Pregnancy

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1. Dr. David Healy says

   July 22, 2025 at 5:08 pm

   FDA panel promotes misinformation about antidepressants during pregnancy, psychiatrists say July 22, 2025, By Aria Bendix
   https://www.nbcnews.com/health/mental-health/fda-panel-promotes-misinformation-antidepressants-pregnancy-psychiatri-rcna220047

   A Food and Drug Administration panel discussing the use of antidepressants during pregnancy Monday largely amounted to misinformation or facts taken out of context, according to several psychiatrists who tuned in to the meeting.

   The panel had promised to feature diverse viewpoints about antidepressants and pregnancy. But nearly all of the 10 panelists bucked medical consensus on the drugs’ safety and emphasized what they said were risks of taking the drugs while pregnant — such as causing autism, miscarriages or birth defects. In some cases, they claimed that antidepressants don’t work at all and that depression goes away on its own.

   Three of the 10 panelists were from outside the United States. Another runs a clinic to help people taper off of psychiatric drugs.

   “They were really rousing concerns about safety that are not evidence-based or established and not at all balanced with concerns about the risks of untreated depression,” said Dr. Joseph Goldberg, a clinical professor of psychiatry at the Icahn School of Medicine at Mount Sinai in New York City.

   Dr. Jennifer Payne, director of the Reproductive Psychiatry Research Program at the University of Virginia, said, “I’m disappointed that the FDA brought people in from outside of the United States when there’s so many experts here in the United States who truly know this [medical] literature inside and out.”

   A spokesperson for the FDA said in a statement that the claim that the panel was one-sided was “insulting to the independent scientists, clinicians, and researchers who dedicate their expertise to these panels.” The spokesperson added that FDA Commissioner Martin Makary “has an interest in ensuring policies reflect the latest gold standard science and protect public health.”

   Health and Human Services Secretary Robert F. Kennedy Jr. has called for a probe into the risks of antidepressants. His “Make America Healthy Again” report in May claimed there were “potentially major long-term repercussions” associated with use of the drugs in childhood.

   The panel discussion focused on a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, which includes Lexapro, Prozac and Zoloft. The medications increase levels of serotonin, a chemical messenger in the brain that can improve mood.

   Psychiatrists often advise women who are taking SSRIs to continue doing so during pregnancy, since the risks of untreated depression tend to outweigh the potential risks of the medication to mother and child. However, the decision is a personal one.

   For ethical reasons, there are no randomized-control trials of SSRIs in pregnant women, meaning data on potential risks mostly comes from observational studies and drug registries.

   Some babies born to mothers taking SSRIs may develop symptoms such as jitteriness, irritability or difficulty eating or sleeping that resolve quickly — what’s known as “neonatal adaptation syndrome.” The symptoms may be caused by medication in the babies’ systems or withdrawal from it.

   Certain studies have also found a slightly elevated risk of miscarriage associated with antidepressant use in pregnancy, though others have found no association. However, there’s no convincing evidence to suggest that SSRIs are linked to autism or birth defects.

   “Well-controlled studies continue to not find an association,” Payne said.

   Women with histories of depression are also at an increased risk of symptoms’ recurring during pregnancy, and depression can come with its own risks — including thoughts of self-harm or low birth weight.

   “The best thing a pregnant individual could do for herself and her baby is to get the treatment that they need,” said Dr. Nancy Byatt, a perinatal psychiatrist at UMass Chan Medical School, who wasn’t part of the panel.

   In addition to raising concerns about side effects, several panelists questioned the efficacy of antidepressants or suggested that data favoring the use of SSRIs was manipulated by the pharmaceutical industry.

   “It’s been said that SSRIs help people who are severely depressed. They don’t,” said David Healy, an FDA panelist and fellow at the Royal College of Psychiatrists in the United Kingdom.

   Goldberg and other psychiatrists said that’s simply untrue.

   “You can say the moon landing was faked. Conspiracy theories abound in our world. But there is not a doubt about whether SSRIs work,” said Goldberg, a past president of the American Society of Clinical Psychopharmacology who has previously consulted for pharmaceutical companies. He said he was invited to join the FDA panel but declined because the language of the invitation suggested it wouldn’t be a fair discussion.
   Healy, the panelist, also claimed that some people “recover spontaneously” from depression.

   Another panelist, psychologist Roger McFillin — who hosts a podcast that challenges conventional mental health advice — suggested that depression wasn’t an illness but rather a product of “women just naturally experiencing their emotions more intensely.” He added, without evidence, that many women feel coerced into taking antidepressants.

   Psychiatrists who weren’t part of the discussion broadly decried those characterizations.

   “I have never, ever, ever, ever heard of a third party pushing a prescription in pregnancy,” Goldberg said. However, he said he is aware of some obstetrician-gynecologists who aren’t as familiar with SSRIs who have wrongly told pregnant patients to stop taking the medications.
   The American College of Obstetricians and Gynecologists said in a statement Monday that SSRIs can be lifesaving for some pregnant people.
   “Today’s FDA panel on SSRIs and pregnancy was alarmingly unbalanced and did not adequately acknowledge the harms of untreated perinatal mood disorders in pregnancy,” it said. “On a panel of 10 experts, only one spoke to the importance of SSRIs in pregnancy as a critical tool, among others, in preventing the potentially devastating effects of anxiety and depression when left untreated during pregnancy.”
   One panelist, Dr. Kay Roussos-Ross, a psychiatrist and an OB-GYN at the University of Florida College of Medicine, was the most vocal advocate for using SSRIs, often pushing back against others’ assessments of the risks. Psychiatrists who weren’t on the panel praised her science-backed commentary.
   “All of us can find a study that agrees with exactly what we think,” Roussos-Ross told the panel. “But we need to look at the data very objectively.”

   Several psychiatrists who weren’t on the panel said they worry that the discussion could lead to regulatory action that makes it harder to access SSRIs. For example, one panelist, Dr. Adam Urato, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Massachusetts, called for stronger warnings on SSRI labels.

   “I am just very nervous that some of the discourse around the risks of antidepressants could lead to even more barriers for people seeking care,” said Dr. Lindsay Lebin, an assistant professor of psychiatry at the University of Colorado Anschutz Medical Campus, who wasn’t part of the FDA discussion.

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2. David T Healy says

   July 23, 2025 at 12:00 am

   https://www.motherjones.com/politics/2025/07/the-fda-held-a-misinformation-fest-about-antidepressants-in-pregnancy/?utm_source=mj-newsletters&utm_medium=email&utm_campaign=daily-newsletter-07-22-2025

   Julianne McShane of Mother Jones reported the meeting like this”

   The FDA Held a Misinformation Fest About Antidepressants in Pregnancy
   A newly-constituted panel repeated what one women’s health expert called “MAHA talking points.”

   Health and Human Services Secretary Robert F. Kennedy Jr. has long railed against antidepressants, and now he has very practical ways to attack them.
   As my colleague Kiera Butler has written, Kennedy has claimed, without evidence, that they can cause addiction and school shootings. He even proposed sending people who take them to “wellness farms,” where they can grow their own organic foods, get “re-parented,” and wean themselves off antidepressants and other medications.

   But on Monday, the Food and Drug Administration (FDA) appeared to move closer towards realizing RFK’s goal of getting people off the drugs, quietly convening a so-called expert panel to discuss selective serotonin reuptake inhibitors—a type of antidepressant commonly known as SSRIs—and pregnancy. The two-hour panel was livestreamed and is available to watch on the FDA’s YouTube page. It was moderated by a pair of FDA staffers, who gave each panelist five minutes to make an opening presentation and then asked a few questions submitted by the public. While 13 percent of Americans use antidepressants, whose efficacy varies but have been shown to help at least 20 percent of people who take them, a far smaller number of pregnant women—research suggests six to ten percent—are on them.

   Many of the panel’s ten participants—a combination of researchers and practicing psychologists, several of whom have publicly spoken out against the use of antidepressants—largely repeated what one women’s health expert called “MAHA talking points” against medications and the biological legitimacy of anxiety and depression. Often, panelists’ arguments were so full of misinformation that Steven Fleischman, the president of the American College of Obstetricians and Gynecologists (ACOG), a professional group for OB-GYNs, promptly put out a statement calling the panel “alarmingly unbalanced” and alleging that the majority “did not adequately acknowledge the harms of untreated perinatal mood disorders in pregnancy.”

   There are, indeed, major mental health struggles facing American moms. Research published by the Centers for Disease Control and Prevention (CDC) in 2020 found that approximately one in eight women experience postpartum depression (PPD) after giving birth, which can lead to difficulties bonding, developmental delays for the infant, and other negative health outcomes. The latest CDC data, from 2017 to 2019, shows that mental health conditions, including suicides and overdoses, were the leading underlying causes of pregnancy-related deaths. The picture has only grown more dire recently: Research published in February in the Journal of Health Economics and Outcomes found that the Supreme Court’s decision overruling Roe v. Wade led to an increase in PPD diagnoses in states with abortion bans compared to those without. Another large study, published in the May issue of JAMA Internal Medicine, found that American mothers reported large declines in their mental health from 2016 to 2023, with single and low-income mothers reporting particularly large drops.

   But listening to the FDA panel on Monday, you would be forgiven for thinking that perinatal depression—which refers to depression both during and after pregnancy—is not, in fact, real.

   In his introductory remarks, FDA Chief Dr. Martin Makary—an abortion opponent and a former surgeon and professor at the Johns Hopkins School of Medicine—called for more study of the “root causes” of perinatal depression. “We have to talk about the role of healthy relationships, of communities, of natural light exposure, of other modalities and co-factors that may be involved,” he said.

   Another panelist, Dr. Josef Witt-Doerring, a psychiatrist whose practice focuses on weaning people from their psychiatric medications, similarly claimed that in contrast to physical conditions, it is impossible to point to distinct causes for mental health disorders. Instead, he claimed, personal problems like loneliness and job dissatisfaction tend to trigger depression. “These are not things to be fixed with medical intervention,” added Witt-Doerring, who also runs a YouTube channel that spotlights the stories of people who have faced adverse side effects from taking psychiatric medications.

   Women are “naturally experiencing their emotions more intensely, and those are gifts. They’re not symptoms of a disease.” Roger McFillen, a psychologist and host of a podcast on which he and guests have railed against vaccines and birth control, suggested that women are “naturally experiencing their emotions more intensely, and those are gifts. They’re not symptoms of a disease.” McFillen also suggested, without evidence, that “many women feel coerced” to get on medications to treat perinatal depression.
   I reached out to Wendy N. Davis, a psychotherapist and the president and CEO of Postpartum Support International, to get her take on the panelists’ characterization of perinatal depression. “That kind of thinking is not evidence-based,” she said, “and not even anecdotally true.” Indeed, physicians and researchers who treat and study PPD note that a combination of genetics, a history of anxiety and depression, and psychosocial factors can play a role in the development of the disorder. Experts say it can be effectively treated through a combination of therapy, medication, and support groups.

   David Healy, a former professor of psychiatry at McMaster University in Canada and Bangor and Cardiff Universities in the UK, agreed with Witt-Doerring, claiming that people with depression and melancholia, a severe type of depression, can often “recover spontaneously,” even within a few months. But the American Academy of Pediatrics recommends that new parents should repeatedly be screened for PPD until the baby is six months old, noting that, if left untreated, it can lead to “long-term adverse health complications.” A 2020 study published in the journal Pediatrics found that 25 percent of nearly 5,000 mothers studied had higher rates of PPD at some point in the three years after giving birth.

   Then there was the misinformation about actually treating perinatal depression with medication. Several of the panelists suggested, for example, that the use of SSRIs during pregnancy can lead to an increased risk of autism in infants. But while some studies have found a higher occurrence of autism in these babies, researchers have cautioned against drawing a causal inference, and several large studies have found no association at all between SSRI use in pregnancy and autism.

   Another claim repeated by many panelists was that doctors have withheld information about the risks of SSRIs from pregnant patients. In response, Fleischman, from ACOG, explained, “Patients who choose to continue taking SSRIs during pregnancy with the support of their OBGYNs do so following counseling on the risks and benefits that includes discussion of the data and consideration of their own needs, values, and priorities.”

   “The claim that the FDA’s expert advisory process is ‘one-sided’ or politically driven is insulting to the independent scientists, clinicians, and researchers who dedicate their expertise to these panels.”

   Panelists offered several suggestions for the path forward. They argued the FDA should strengthen its warnings about SSRI use during pregnancy to include more information about the impacts on preterm birth, preeclampsia, and postpartum hemorrhage. “There is now more than enough evidence to support strong warnings from the FDA about how these drugs disrupt fetal development and impact moms,” panelist Adam Urato, chief of maternal-fetal medicine at MetroWest Medical Center in Massachusetts, claimed. But studies show that SSRIs have only small or negligible impacts on the health issues that Urato raised.

   A spokesperson for HHS said the agency would not comment on potential future policy decisions, adding, “The claim that the FDA’s expert advisory process is ‘one-sided’ or politically driven is insulting to the independent scientists, clinicians, and researchers who dedicate their expertise to these panels.”

   Dr. Kay Roussos-Ross, an OBGYN and the director of the Perinatal Mood Disorders program at the University of Florida College of Medicine, was a rare expert in this group who pointed out that research has shown how untreated depression and anxiety in pregnancy can lead to a host of health problems for the pregnant person and their baby, including preterm delivery, inadequate prenatal care, substance abuse, and developmental delays for the child. Roussos-Ross also pointed to one study that revealed women who stopped taking medications in pregnancy were five times more likely to experience a relapse of symptoms compared to those who remained on them. “Not every single woman will need an antidepressant,” Roussos-Ross said during the panel, “but for those that do, it’s life-changing and life-saving.”

   Jen Gunter, an OB-GYN and author of three books on menstruation, menopause, and vaginal health, called most of the panelists “depression deniers” who did not share basic evidence-based information. In a post on Bluesky, she praised Roussos-Ross for “shutting down all the others who were fear-mongering.”

   Davis, from Postpartum Support International, said she just hopes struggling mothers understand that there is evidence-based help out there. “A mom can’t call the FDA panel,” she said, “and it’s not going to help her to listen to it.”

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3. David T Healy says

   July 23, 2025 at 12:00 pm

   Healio covered the issues as follows
   https://www.healio.com/news/womens-health-ob-gyn/20250721/fda-panel-weighs-risks-benefits-of-antidepressants-during-pregnancy

   FDA panel weighs risks, benefits of antidepressants during pregnancy
   ByAndrew (Drew) Rhoades Fact checked byCarol L. DiBerardino, MLA, ELS
   Key takeaways:
   • Panel members said SSRI use during pregnancy has been tied to adverse fetal outcomes.
   • An expert told Healio the risks of untreated depression “is greater than the risks of SSRIs.”
   Members of an FDA expert panel discussed the risks and benefits of selective serotonin reuptake inhibitors, or SSRIs, for depression during pregnancy, with some calling for stronger warning labels.
   According to ACOG, about one in 10 pregnant women face depression, which can increase the risk for early labor, low birth weight and postnatal health complications.
   \FDA Commissioner Martin Makary, MD, MPH, said SSRIs “can be an effective treatment for depression,” but he also said “serotonin may play a crucial role in the development of organs of a baby in utero,” including the heart, brain and gut. Further, he said “SSRIs have also been implicated in different studies to postpartum hemorrhage, pulmonary hypertension and cognitive downstream effects in the baby, as well as cardiac birth defects.”
   However, Tiffany A. Moore Simas, MD, MPH, MEd, MHCM, a professor of OB/GYN, pediatrics, psychiatry and behavioral science and population & quantitative health sciences at the University of Massachusetts Chan Medical School, told Healio “it is incredibly important to present the risks of untreated perinatal mental health conditions, which in addition to having significant negative consequences for pregnant persons, offspring and families, are the leading cause of overall and preventable maternal mortality via suicide and overdose.”
   “People don’t get to choose whether or not they have mental health conditions. They do get to choose how to treat them,” Moore Simas, who was not part of the panel discussion, said.
   Adverse health outcomes
   During the discussion, several panelists highlighted the potential negative outcomes associated with antidepressants, especially in newborns.
   Anick Bérard, PhD, a professor of perinatal epidemiology at the University of Montreal, said SSRIs during pregnancy have been tied to a higher risk for spontaneous abortion, congenital malformations, prematurity, low birth weight and ADHD or autism, “with an increased risk ranging from 10% to 87%, depending on the adverse pregnancy outcome.”
   According to Mayo Clinic, the link between autism and antidepressants during pregnancy warrants more research, “but most studies have shown that the risk is very small,” while some “have shown no risk at all.”
   Other reports suggest that there are no significant associations between SSRIs and an increased risk for spontaneous abortion or ADHD, according to the MGH Center for Women’s Health.
   Bérard added that SSRIs are “not the miracle solution” to depression because “12% of women who are using SSRIs remain depressed in pregnancy,” which she said could be attributed to “suboptimal use or inappropriate dosing.”
   Additionally, Jay Gingrich, MD, PHD, director of the Institute for Developmental Sciences, said there is some evidence to suggest that prescribing SSRIs during pregnancy may worsen outcomes in offspring, including a greater risk for depression during adolescence.
   Adam Urato, MD, chief of maternal-fetal medicine at MetroWest Medical Center, said there is “widespread scientific agreement” that SSRIs influence fetal brain development, and long-term studies have shown higher rates of speech and language difficulties in addition to autism and depression.
   “If serotonin plays a crucial role in the fetal development, and it does, and if the SSRIs cross the placenta and disrupt the serotonin system, which they do, then the SSRIs must disrupt fetal development,” he said, noting that human and animal studies show “that SSRIs impact individual neurons in the developing brain.”
   FDA warning labels need alteration
   Urato said that “a big part of compassionate care is giving patients the proper information about risks and benefits of treatment and then supporting their choices.”
   According to Urato, most women say they have been counseled only that SSRIs “do not affect the baby or cause complications.”
   He pointed out there is currently no warning for preeclampsia or preterm birth on the drug labels.
   Literature on the link between preeclampsia and SSRIs is mixed. According to the MGH Center for Women’s Health, for example, a meta-analysis on nine studies revealed a small but statistically significant increased risk for preeclampsia in SSRI-exposed pregnancies. However, the center acknowledged that most studies do not account for preeclampsia risk factors, and it is “biologically possible” that antidepressants, which improve serotine regulation, may actually help “decrease vulnerability to preeclampsia.”
   Regarding preterm birth, a 2024 study published in npj Women’s Health showed that antidepressants did not increase preterm birth risk. However, there was a 10% greater risk for women with a history of depression who did not take SSRIs during pregnancy vs. those without a history of depression.
   Urato also said “the postpartum hemorrhage warning needs to be strengthened, but perhaps the major shortcoming is the label doesn’t make clear that SSRIs alter fetal brain development.”
   Meanwhile, Josef Witt-Doerring, MD, a psychiatrist at Taperclinic, said that warning labels need to provide more information about tapering and the risk for withdrawal.
   “Why are we not telling women about the risks of these medications and how challenging it can be to come off in a timely fashion?” he asked.
   Witt-Doerring also pointed out inconsistencies when it comes to the medication guides of drugs within the same class.
   “Lexapro may harm the unborn baby in one medication guide, [but] Zoloft does not emphasize that — it emphasizes withdrawal,” he said. “It doesn’t make sense that we should have inconsistent medication guide labeling.”
   In a statement, ACOG said the panelists had many “outlandish and unfounded claims,” one of which is that “patients are deceived or inadequately counseled by their doctors.”
   Untreated depression also raises risks
   Kay Roussos-Ross, MD, a professor and director of the perinatal mood disorders program at the University of Florida College of Medicine, said “treating mental illness is not a luxury, it is a necessity,” and certain risks like preterm delivery are higher when women are not treated.
   According to Roussos-Ros, perinatal mood disorders affect 20% of pregnant people in the U.S.
   “Despite this prevalence, at least half of affected women go untreated or undertreated during their pregnancy and postpartum, and this is due to several reasons, including inadequate identification, inadequate access to care and stopping of medications for treatment,” she said.
   In addition to preterm delivery, Roussos-Ross said the risks of untreated depression include small for gestational age and inadequate bonding and attachment, which can then decrease socialization in youth.
   “When mental health conditions go untreated, these women are less likely to attend their prenatal care appointments and are more likely to use substances during their pregnancy,” she said. “They are also more likely to face additional risks such as preeclampsia and cesarian delivery.”
   Roussos-Ross said suicide is another major risk “as one of the leading causes of maternal death in the U.S. is mental health.”
   Although there are several effective treatment options, Roussos-Rose said SSRIs are among “the most-studied medications in pregnancy.”
   “When we review the literature and account for confounding variables, comparing patients with depression who were untreated vs. patients who are with depression and medications, we actually see that the risks are very similar between the two groups” for most conditions, she said.
   Based on current evidence, “which is agreed upon by many professional societies, the risks of untreated mental health are significant, and SSRIs should be considered as one of the treatment options with shared decision-making with our patients,” Roussos-Ross said.
   Shared decision-making ‘essential’
   Members repeatedly emphasized the need for shared decision-making between pregnant patients and health care providers.
   “The importance of informed decision-making in pregnant women is essential,” Bérard said. “Pregnant women will be the ones making the decision, and they will be acknowledging the risks and benefits for themselves if it is well explained to them.”
   Bérard said the prevalence of anxiety and pregnancy since the COVID-19 pandemic has more than doubled, which “warrants increased monitoring for both the mother and the children in the coming decade, particularly among those in the vulnerable population.”
   Moore Simas told Healio that discussions about the risks of treatment “must be balanced with information about not treating.”
   “The evidence on balance supports treatment, especially given early data have many limitations, including use of inappropriate comparison groups, and more contemporary advanced analytic methodologies have improved our ability to address confounding by indication and interpretation,” she said. “For most patients with active depression or anxiety symptoms, the risks of untreated disease [are] greater than the risks of SSRIs.”
   Editor’s note: This is a developing news story. Please check back soon for more details.
   References:
   • Amit G, et al. npj Women’s Health. 2024;doi:10.1038/s44294-024-00008-0.
   • Antidepressants: Safe during pregnancy?. Available at: https://www.mayoclinic.org/healthy-lifestyle/pregnancy-week-by-week/in-depth/antidepressants/art-20046420. Published July 22, 2025. Accessed July 22, 2025.
   • ACOG Statement on the Benefit of Access to SSRIs During Pregnancy. Available at: https://www.acog.org/news/news-releases/2025/07/statement-on-benefit-of-access-to-ssris-during-pregnancy. Published July 21, 2025. Accessed July 22, 2025.
   • Depression during pregnancy. Available at: https://www.acog.org/womens-health/faqs/depression-during-pregnancy. Accessed July 21, 2025.
   • Does SSRI use in pregnancy raise the risk of depression in teens? Available at: https://www.cuimc.columbia.edu/news/does-ssri-use-pregnancy-raise-risk-depression-offspring. Published May 6, 2025. Accessed July 21, 2025.
   • Essential reads: SSRI antidepressants during pregnancy and risk of hypertension, preeclampsia. Available at: https://womensmentalhealth.org/posts/essential-reads-ssri-during-pregnancy-hypertension-preeclampsia. Published April 4, 2023. Accessed July 21, 2025.
   • Essential reads: SSRI antidepressants do not increase risk of miscarriage. Available at: https://womensmentalhealth.org/posts/essential-reads-ssri-antidepressants-do-not-increase-risk-of-miscarriage/. Published Jan. 6, 2021. Accessed July 22, 2025.
   • No link between prenatal exposure to antidepressants and risk for ADHD in offspring. Available at: https://womensmentalhealth.org/posts/no-link-between-prenatal-exposure-to-antidepressants-and-risk-for-adhd/. Published Jan. 3, 2023. Accessed July 22, 2025.
   • Untreated depression increases preterm birth risk, not antidepressants. Available at: https://www.marchofdimes.org/our-work/research/blog/antidepressants-dont-increase-risk-preterm-birth-untreated-depression-does-ucsf-prc. Published April 11, 2024. Accessed July 22, 2025.
   • Zanni G, et al. Nat Commun. 2025;doi:10.1038/s41467-025-58785-4.
   Tiffany A. Moore Simas, MD, MPH, MEd, MHCM, can be reached at primarycare@healio.com.

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4. David T Healy says

   July 23, 2025 at 12:07 pm

   https://www.biopharmadive.com/news/fda-panel-ssri-antidepressant-pregnancy-risks-warning/753586/

   Biopharma Dive covered it like this:
   FDA panel elevates concerns over antidepressant use during pregnancy
   A group of experts convened by the agency argued for stricter warnings around SSRI drugs, at times echoing claims made by HHS Secretary Robert F. Kennedy Jr.

   Published July 22, 2025 Delilah Alvarado Staff Reporter

   The Food and Drug Administration on July 21, 2025, convened a panel of outside experts to discuss antidepressant drug use in pregnant women.

   A group of outside experts convened Monday by Food and Drug Administration Commissioner Martin Makary questioned the benefits and safety of antidepressant use in pregnant women and called for stricter labeling of the drugs.

   The panel raised concerns specifically about the risks of selective serotonin reuptake inhibitors, a common type of antidepressant that Health and Human Services Secretary Robert F. Kennedy Jr. has criticized as overprescribed.

   No consensus emerged from Monday’s meeting, nor did FDA officials indicate any action they plan to take next.

   The panel followed a similar pattern as one hosted to discuss hormonal menopause therapy Thursday. Many of the experts invited to attend held similar views as each other, generally opposing SSRI use in pregnant women.

   Opening Monday’s meeting, Makary said that while SSRIs can be effective, they can also pose risks. He also raised concerns about how widespread their use has become, drawing comparisons to rising rates of other conditions.

   “The more antidepressants we prescribe, the more depression there is. The more insulin we prescribe, the more diabetes there is,” Makary said. “I’m not suggesting that these medications, or any medications, are causative of mass explosions of disease from an epidemic standpoint, but we have to start talking about root causes.”

   SSRIs are typically prescribed for depression, but can also treat anxiety and other psychological conditions. The class of drugs includes well-known brands like Lexapro, Prozac and Zoloft.

   Physicians typically adopt a personalized approach when treating mental health disorders during pregnancy, taking into account factors like mental health history, which medication to recommend and any potential risks.

   While there is some concern of neurodevelopmental disorders in newborns following antidepressant use during pregnancy, other research has found evidence for such a link to be weak and unlikely to be causally related to the medicines.

   Depression during pregnancy can also lead to complications, including postpartum depression, if untreated. And despite its prevalence, depression in pregnant women is often undertreated or untreated altogether.

   Some of the panel experts even argued against the benefits of SSRIs directly. “It’s really important to appreciate that there is very little evidence that antidepressants have actual benefits in depression,” claimed Joanna Moncrieff, a practicing psychiatrist and professor of critical and social psychiatry at University College London, who attended virtually.

   Others on the 10-person panel agreed that better warnings were needed for the drugs, but gave different reasons for why.

   Adam Urato, chief of maternal fetal medicine at MetroWest Medical Center in Massachusetts, said SSRIs have been linked to various pregnancy complications and birth defects in both animal and human studies, and called for better risk information.

   “What are we waiting for before we warn the public?” Urato said.

   Josef Witt-Doerring, a former FDA official and now a psychiatrist at TaperClinic, which helps people quit psychiatric drugs, highlighted how stopping SSRI treatment can be difficult for some. Kennedy has talked often about this issue, falsely claiming that SSRIs can be as difficult to quit as heroin.

   Stopping antidepressant treatment can cause withdrawal symptoms such as nausea, headaches or mood swings that can range in severity depending on the length of treatment.

   “I think for a long time we’ve taken a lot of pride in this country about being the epicenter of pharmaceutical development,” Witt-Doerring said. “But we should also take a lot of pride in informing the people who live here, our citizens, about the risks of these medications.”

   One panelist, Kay Roussos-Ross, advocated for continued use of SSRIs in pregnant women.

   “All of us can find a study that agrees with exactly what we think,” said Roussos-Ross, who is a professor at the University of Florida College of Medicine and director of a perinatal mood disorders program there. “But we need to look at the data very objectively, and think about all the confounding factors that also affect outcomes in infants, fetuses and children,” she said.

   Roussos-Ross said the panel should focus on how the risks of treatment balance against the risks of untreated depression in pregnant women, and argued medications should remain available for those who need them.

   “Not every single woman will need an antidepressant, but for those that do, this is life-changing, and this is lifesaving,” Roussos-Ross said.

   Roussos-Ross added that more research should be done in pregnant women, a group that has been neglected in clinical trials due to fear of harm.

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5. Dr. David Healy says

   July 23, 2025 at 12:19 pm

   https://www.contemporaryobgyn.net/view/fda-panel-convenes-on-ssris-and-pregnancy-amid-ongoing-debate-over-risk-efficacy

   Contemporary ObGyn

   FDA panel convenes on SSRIs and pregnancy amid ongoing debate over risk, efficacy
   July 21, 2025 By Morgan Ebert, Managing Editor Fact checked by Celeste Krewson, Ass Editor
   The US Food and Drug Administration (FDA) convened a public expert panel to discuss the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy, highlighting a contentious and complex issue that affects millions of women in the United States. The panel brought together perinatal psychiatrists, developmental biologists, epidemiologists, obstetricians, and mental health experts to assess the current state of evidence on SSRIs, including their risks, benefits, and regulatory implications.
   FDA Commissioner Marty Makary, MD, MPH, opened the session by acknowledging that “nearly 1 in 4 middle-aged women are on an antidepressant, and up to 5% of women in pregnancy are on an antidepressant.” While recognizing the potential benefit of SSRIs, he cautioned that the broader picture of mental health in the United States has not improved despite increasing prescriptions. “The more antidepressants we prescribe, the more depression there is,” he said, adding, “We have to start talking about root causes.”
   Anick Bérard, PhD, professor of Perinatal Epidemiology, University of Montreal, faculty of Pharmacy, and CHU Ste-Justine in Montreal, and adjunct professor at the Faculty of Medicine, Université Claude Bernard, stated that depression and anxiety in pregnancy are prevalent and require treatment. “Untreated depression and anxiety during pregnancy has been shown to be associated with an increased risk of postpartum depression,” she said. She emphasized the complexity of risk-benefit analysis for antidepressant use in pregnancy and noted that the absolute risk of outcomes such as miscarriage or autism remains low, even if relative risk appears elevated in some studies.
   Jay Gingrich, MD, PhD, director, Institute for Developmental Sciences, and professor of Developmental Psychology (in Psychiatry), Columbia University Irving Medical Center, presented findings from large-scale studies linking in utero SSRI exposure to increased rates of adolescent depression. “Until recently, there’s really never been any attempt to study whether this treatment of the mother actually improves outcomes in the offspring,” he noted. Gingrich also emphasized that serotonin plays a different developmental role in utero than in adults, acting as a neuromodulator that influences organ and neural development.
   Adam Urato, MD, chief of Maternal-Fetal Medicine at MetroWest Medical Center, called for stronger FDA warnings. “Patients regularly tell me that essentially the only counseling they received is that SSRIs don’t affect the baby or cause complications. This is simply not accurate,” he said. He cited data from animal studies and human imaging studies to assert that SSRIs alter fetal brain development. “The SSRIs can be very difficult to get off of, so the time to think about these things is long before pregnancy,” he added.
   Some panelists, such as Kay Roussos-Ross, MD, took a different position. “One in 5 women will have a perinatal mood disorder,” she said. “Psychotherapy and SSRIs are tools that we have… Treating mental illness in pregnancy is not a luxury. It’s a necessity.” Roussos-Ross cited guidelines from multiple professional societies and argued that the risks of untreated mental illness often outweigh those of SSRI exposure, especially when factoring in increased rates of preterm birth, poor prenatal care, and maternal suicide.
   Roussos-Ross is a professor and chief in the Division of Academic Specialists in General Obstetrics and Gynecology, and director of the Perinatal Mood Disorders Program in the Department of Obstetrics and Gynecology and Psychiatry at the University of Florida College of Medicine.
   However, several participants questioned the foundational premise of SSRI efficacy. Joanna Moncrieff, MD, professor of Critical and Social Psychiatry at University College London and practising psychiatrist, stated, “There is very little evidence that antidepressants have actual benefits in depression.” She argued that perceived improvements may stem from nonspecific psychoactive effects rather than the correction of a biochemical imbalance.
   Multiple speakers also criticized the prevailing “chemical imbalance” narrative. Jeffrey Lacasse, PhD, MSW, associate professor, College of Social Work, Florida State University, noted, “88% of Americans believe that antidepressants correct chemical imbalances, despite no conclusive scientific basis.” He suggested this belief contributes to overprescribing, including among women of reproductive age.
   Michael Levin, PhD, distinguished professor, Department of Biology and Director of the Allen Discovery Center at Tufts University, provided evidence that serotonin signaling plays a critical role in early embryonic patterning and organ asymmetry. “Manipulating its use by cells with SSRIs is very, very likely to cause certain kinds of defects,” he said, referencing experiments in frogs and chicks.
   In addressing regulatory implications, a psychiatrist at Taperclinic and former FDA medical officer Josef Witt-Doerring, MD, highlighted that even known risks like neonatal withdrawal and cardiac malformations are inconsistently addressed across SSRI drug labels. He proposed more accessible patient education, such as QR codes on prescription bottles linking to FDA-approved risk summaries.
   The panel did not reach consensus on new regulatory action, but many agreed that greater transparency, improved labeling, and expanded access to nonpharmacologic interventions are needed. “The key is information,” said Urato. “Never before in human history have we chemically altered developing babies like this… without any real public warning.”
   The FDA has not yet announced whether it will revise current SSRI labeling or issue new guidance. However, the agency indicated it would consider the panel’s input in evaluating potential policy updates.
   Reference:
   FDA. FDA Expert Panel on Selective Serotonin Reuptake Inhibitors (SSRIs) and Pregnancy. FDA July 21, 2025. Accessed July 21, 2025. https://www.youtube.com/watch?v=2Nha1Zh63SA

   Reply

6. Dr. David Healy says

   July 23, 2025 at 12:30 pm

   https://www.medpagetoday.com/psychiatry/depression/116610

   Medpage Today covered the meeting as follows:

   FDA Panel Takes Aim at SSRI Use During Pregnancy
   Experts said women should be informed of possible risks, but data on such risks are mixed
   by Kristen Monaco, Senior Staff Writer, MedPage Today July 21, 2025
   Women should be better informed about the potential risks of using selective serotonin reuptake inhibitors (SSRIs) during pregnancy, and these risks should be weighed against their benefits, most speakers on an FDA panelopens in a new tab or window selected by Commissioner Marty Makary, MD, MPH, agreed on Monday.
   “Up to 5% of women in pregnancy are on an antidepressant. Antidepressants like SSRIs can be an effective treatment for depression,” said Makary during his opening remarks, though he warned that SSRIs “may be unique” because of their potential interaction with pregnancy.
   “Serotonin may play a crucial role in the development of organs of a baby in utero, specifically heart, brain, and even the gut,” he continued. “SSRIs have also been implicated in different studiesopens in a new tab or window to be involved in postpartum hemorrhage, pulmonary hypertension, and cognitive downstream effects in the baby, as well as cardiac birth defects.”
   Some of the 10 panelists — consisting of experts in psychology, psychiatry, and ob/gyn — have spoken out against SSRIsopens in a new tab or window for years, dismissed the entire class as “placebos,” and published papers linking the drugs to autismopens in a new tab or window and other conditions in offspring.
   During Monday’s discussion, some panelists suggested that the risks of prenatal SSRI use on offspring have flown under the radar for the past few decades. Others potential risks flagged in prior studies include possible behavioral-related risks, attention deficit-hyperactivity disorder (ADHD)opens in a new tab or window, depression, and anxiety.
   None of these outcomes have been verified in randomized, placebo-controlled trials since pregnant women are typically excluded from such studies. Observational studies have suggested these outcomes, and some studies have reported conflicting findingsopens in a new tab or window. A few MRI studies in offspring exposed to SSRIs in utero have been conducted, one of whichopens in a new tab or window found an association with changes in brain regions involved in emotional regulation.
   However, the absolute risk for many of these outcomes is low, said Kay Roussos-Ross, MD, of the University of Florida College of Medicine in Gainesville, with the exception of neonatal adaptation syndrome, which occurs in about 25% to 30% of babies exposed late in pregnancy. This can cause jitteriness, irritability, and respiratory distress in affected babies, but typically resolves within a few days to weeks.
   Roussos-Ross was one of the few panelists to highlight the harms of untreated depression in mothers, which should be balanced against any potential risk of SSRI exposure in offspring, she said. “One of the leading causes of maternal death in the U.S. is mental health, including suicide and overdose deaths.”
   “Research shows that in women who stop their medications in pregnancy, they are five times more likelyopens in a new tab or window to experience a relapse in their mood symptoms compared to those who continued their medications during pregnancy,” she noted.
   Other adverse outcomes with untreated depression in pregnant women can include preterm delivery, cesarean delivery, small-for-gestational-age babies, a lower likelihood of attending prenatal care appointments, a higher likelihood of using substances during pregnancy, preeclampsia, and inadequate bonding and attachment difficulty with their children, she said.
   Agreeing with Roussos-Ross, Jay Gingrich, MD, PhD, of Columbia University Irving Medical Center in New York City, said SSRIs shouldn’t be withheld from pregnant women with depression, but women should be better informed of their risks.
   “There needs to be a stronger warning in the warning section,” added Adam Urato, MD, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Massachusetts. He proposed adding a boxed warning to the label of all SSRIs, “so people realize the impact these chemicals … have on the developing baby and pregnancy complications on mom, as well.”
   Former FDA official Josef Witt-Doerring, MD, who now runs a clinic that aims to help patients taper off psychiatric medications, raised concerns about inconsistent labeling across the SSRI class, citing the example of escitalopram (Lexapro) and sertraline (Zoloft), which currently tout different language on their labels to warn about potential harms to unborn babies.
   He suggested the FDA get more creative in disseminating drug risk information. “If we could get QR codes with patient-friendly videos talking about the most important risks right on the bottle cap that says ‘watch me,’ we could do wonders,” he said.
   But David Healy, MD, a fellow of the Royal College of Psychiatrists, said the responsibility of educating patients about the risks should fall on the prescribing doctors, not the FDA. “Make doctors great again,” he said.
   Many of the panelists advocated for greater uptake of alternative treatment options for depression in pregnant women, including psychotherapy and other pharmacological options such as tricyclic antidepressants like nortriptyline and atypical antidepressants like bupropion.
   A few panelists made controversial claims during Monday’s discussion, including dismissing SSRIs altogether by questioning their efficacy. Joanna Moncrieff, MD, of University College London, said the benefits of antidepressants were “barely distinguishable from placebo.”
   Countless studies have shown the benefits of antidepressants, including a meta-analysisopens in a new tab or window of 21 antidepressants, and a randomized trialopens in a new tab or window that showed that adults on antidepressants for a prolonged period were significantly less likely to have a relapse of a depressive episode if they stayed on treatment.
   Advocating against the “medicalization of the human experience,” Roger McFillin, PsyD, executive director of the Center for Integrated Behavioral Health in Bethlehem, Pennsylvania, suggested that women naturally feel their emotions more than men, “which are gifts and not a symptom of disease,” and shouldn’t start on SSRIs to only “become dependent on the medical system.”
   In response to the meetingopens in a new tab or window, Steven Fleischman, MD, MBA, president of the American College of Obstetricians and Gynecologists (ACOG), said that “unfortunately, the many outlandish and unfounded claims made by the panelists regarding SSRIs will only serve to incite fear and cause patients to come to false conclusions that could prevent them from getting the treatment they need.”
   “Robust evidence has shown that SSRIs are safe in pregnancy and that most do not increase the risk of birth defects,” he noted.

   Reply

7. David T Healy says

   July 23, 2025 at 4:00 pm

   FDA to consider warning against antidepressants The Center Square Andrew Rice
   Mon, July 21, 2025 at 8:15 PM GMT+2

   https://www.thecentersquare.com/national/article_9fb0480b-c7d9-4683-b118-cd07a3016b37.html

   (The Center Square) – Doctors on Monday urged the U.S. Food and Drug Administration to issue warnings to pregnant women against the use of certain medications to treat depression, obsessive compulsive disorder and anxiety.

   In a panel discussion Monday, doctors across the medical field and officials at the FDA said women taking selective serotonin reuptake inhibitors to treat illnesses like depression can negatively impact the development of a child in the womb.

   “SSRIs may be unique because serotonin may have an interaction with the physiology of a woman and a woman who is pregnant,” said FDA director Commissioner Marty Makary. “Serotonin may play a crucial role in the development of organs of a baby in utero, specifically heart, brain and even the gut.”

   Several experts on the panel said the FDA does not adequately warn pregnant women about the negative effects of SSRIs on a baby’s development.

   Adam Urato, chief of maternal fetal medicine at MetroWest Medical Center in Massachusetts, said there is widespread scientific support for the dangers of SSRIs on the development of a baby in its mother’s womb.

   “When a pregnant mom takes an SSRI chemical, that chemical enters the mom, crosses the placenta, goes into the developing brain and has chemical effects,” Urato said.

   “Ultrasound studies show SSRI-exposed fetuses have different movement and behavior patterns,” Urato said.

   Urato said the newborn babies can experience jitteriness, breathing difficulties and higher rates of admission to the neonatal intensive care unit if their mother used SSRIs.

   A 2023 study from the National Institutes of Health partly agreed with Urato, but didn’t directly link a mother’s SSRI intake to long term health outcomes for a child.

   Some experts on the panel said SSRIs are still necessary to treat a mother’s depression and prevent a child from inheriting the same illness.

   Kay Russos-Ross, a gynecologist at the University of Florida’s women’s health center, said mothers with mental health issues who do not have access to SSRIs face a greater risk than those continuing the medication throughout pregnancy.

   Russos-Ross said women who are not treated for mental health conditions during pregnancy risk suicide, overdose and inadequate bonding with children. She said lack of treatment can cause decreased socialization, IQ issues, behavioral disorders like attention deficit hyperactivity disorder and depression in children.

   “The risks of untreated mental health conditions are significant and SSRI should be considered as one of the treatment options with shared decision making with our patients,” Russos-Ross said.

   A study from the National Institutes of Health found that a mother’s preexisting psychological condition has more of an effect on the child’s outcomes than exposure to SSRIs in the womb.

   Regardless of the proposed risks, experts across the panel urged the FDA to implement more warnings for pregnant mothers on SSRIs.

   “We should take pride in informing the people who live here, our citizens, about the risks of these medications and we can do a better job,” said Josef Witt-Doerring, a psychiatrist and former FDA medical officer.

   “A big part of compassionate care is giving patients the proper information about risks and benefits of treatment and then supporting their choices,” Urato said.

   Reply

8. David T Healy says

   July 23, 2025 at 4:04 pm

   Fox News gave one of the more balanced accounts:

   https://youtu.be/dDyVWbE7SGs?feature=shared

   Reply

9. David T Healy says

   July 23, 2025 at 4:08 pm

   Psychiatric Times had this to say:
   https://www.psychiatrictimes.com/view/breaking-down-the-fda-advisory-board-meeting-on-ssris-during-pregnancy-with-john-miller-md

   Breaking Down the FDA Advisory Board Meeting on SSRIs During Pregnancy
   Jul 22, 2025 By John J. Miller, MD

   Debate over using SSRIs in pregnancy in recent FDA focus group raises questions, despite extensive research supporting SSRI use for maternal mental health.

   John Miller, MD, Editor in Chief of Psychiatric Times, discusses yesterday’s FDA advisory board focus group on selective serotonin reuptake inhibitor (SSRI) use during pregnancy. Miller says he was “perplexed why this panel met to discuss this topic, since we’ve been using SSRIs since 1987 with the approval of fluoxetine.” He noted that there is a wealth of research data on using these medications during pregnancy, but the panelists reiterated that there was not enough data on the topic. But with over 2000 results on PubMed with keywords “SSRIs” and “pregnancy,” Miller feels confident and impressed with the amount of data available on the subject.1-3 He said of the panelists that there was a “range of people who are really disconnected from direct care of pregnant patients,” and would have liked to see experts in the field such as Dr Lee Cohen and Dr Marleen Freeman weigh in on the discussion. Miller, as a provider, feels “quite comfortable” prescribing SSRIs during pregnancy. Sites like the Center for Women’s Mental Health provide up to date information and a registry on using medications, including SSRIs, during pregnancy. Depression itself is a risk factor during pregnancy for both the mother and child, Miller says. Even with nonpharmacological treatments, Miller strongly encourages clinicians to provide a risk-benefit assessment to pregnant patients around continuing their psychiatric medication during pregnancy. He also disagrees with the panelists’ claim that SSRI use in pregnancy can cause Asperger’s spectrum disorder or alcohol use disorder. Miller says generally he hoped for a “broader and more informed group of experts” to present on this topic, and there was a lack of understanding for the history of research on the use of SSRIs during pregnancy.

   Dr Miller is Medical Director, Brain Health, Exeter, New Hampshire; Editor in Chief, Psychiatric Times; Staff Psychiatrist, Seacoast Mental Health Center, Exeter; Consulting Psychiatrist, Insight Meditation Society, Barre, Massachusetts.

   Reply

10. Dr. David Healy says

    July 23, 2025 at 4:16 pm

    https://www.nytimes.com/2025/07/21/health/antidepressants-ssri-pregnancy-fda.html?unlocked_article_code=1.Yk8.E_m6.8FFX_1DsNuYV&smid=url-share

    The New Yok Times Reported it like this – Ellen Barry July 21, 2025

    Over nearly four decades since Prozac was approved for the treatment of depression, waves of concern about the effects of antidepressants during pregnancy have resulted in a practical consensus: Though use of the drugs may be associated with a slight rise in the odds of birth defects, the risk of leaving a mother’s depression untreated is often greater.

    But a high-level shift is taking place within the Department of Health and Human Services under Secretary Robert F. Kennedy Jr., who has made reducing the prescription of psychotropic drugs a policy priority.

    Among the select group of experts convened by the Food and Drug Administration on Monday to discuss the safety of antidepressants during pregnancy, around half said that women should receive a more clear and forceful warning about potential risks to the fetus.

    Andrew Nixon, an H.H.S. spokesman, said the agency would not comment on whether there were plans to require a so-called black box warning about the use of selective serotonin reuptake inhibitors, or S.S.R.I.s, in pregnancy.

    In his introductory remarks, F.D.A. commissioner Dr. Marty Makary said that “some women are not aware” of the risks of taking antidepressants in pregnancy, suggesting openness to the idea. Around 5 percent of pregnant American women take antidepressants, he said.

    “Serotonin might play a crucial role in the development of organs of a baby in utero,” Dr. Makary said.

    He added that S.S.R.I.s have been “implicated in different studies to be involved in postpartum hemorrhage, pulmonary hypertension and cognitive downstream effects in the baby, as well as cardiac birth defects.”

    After the event ended, some experts who watched the panel described it as unbalanced, favoring prominent critics of antidepressants over those who treat severely ill patients.

    “I am far more concerned about the risks of untreated illness than I am about the risk of medication,” said Dr. Nancy Byatt, a perinatal psychiatrist at the UMass Chan Medical School.

    Studies conducted over many years, on hundreds of thousands of women, have concluded that antidepressants do not cause major harm to the developing fetus, she said.

    Members of the panel were blunt, and, at times, alarming in their comments.

    “The public needs better information, and the F.D.A. must strengthen the warnings,” said Dr. Adam Urato, chief of maternal and fetal medicine at the MetroWest Medical Center in Framingham, Mass.

    “Never before in human history have we chemically altered developing babies like this, especially the developing fetal brain, and this is happening without any real public warning, and that must end,” he said.

    Another panelist, Dr. Josef Witt-Doerring, the founder of a “tapering clinic” that helps patients quit psychiatric medications, said that many women taking antidepressants came to him when they wished to start families. He tells them about risks to the fetus, like congenital heart malformations and neurodevelopmental problems.

    “They’ve never heard of these things, and they feel incredibly betrayed,” he said. “You know, ‘Why didn’t anyone bring this up with me when I got started on this medication?’”

    Among the other panelists invited by the F.D.A. were two British psychiatrists with long records of criticizing the use of psychotropic medication.

    Dr. Joanna Moncrieff is the author of “The Bitterest Pills: The Troubling Story of Antipsychotic Drugs” and “Chemically Imbalanced: The Making of and Unmaking of the Serotonin Myth.” Dr. David Healy has served as an expert witness in homicide and suicide trials involving psychotropic drugs.

    The two-hour panel, which was livestreamed over the F.D.A.’s social media channels, signals a pivot on the question and is likely to add fuel to a grassroots movement that questions the rising use of psychiatric medication.

    Only one panelist, Dr. Kay Roussos-Ross, an expert in postpartum health at the University of Florida, made the case that antidepressants could be a critical tool in treating pregnant women who may use substances or forego prenatal care if they relapse.

    “Not every single woman will need an antidepressant, but for those that do, this is life-changing, and this is lifesaving,” she said.

    Dr. Byatt said a warning from the F.D.A. was not likely to alter the practices of specialists in the field, but it might make women fearful about taking antidepressants.

    “So many women I see feel guilty about taking medications,” said Dr. Byatt, a member of the Council on Women’s Mental Health, which is part of the American Psychiatric Association.

    “They think they should ignore their needs for their babies. And I think it could make their decisions a lot harder, and the conversations we’re having with them a lot harder, because it could cause unnecessary alarm.”

    Christina Caron contributed reporting. Ellen Barry covers mental health for The Times.

    Reply

11. David T Healy says

    July 23, 2025 at 6:48 pm

    National Curriculum in Reproductive Psychiatry
    https://ncrptraining.org/press-release-ncrp-responds-to-fda-panel-on-ssri-use-in-pregnancy/

    The National Curriculum in Reproductive Psychiatry (NCRP) is issuing this response following the recent FDA panel discussion on the use of selective serotonin reuptake inhibitors (SSRIs) in pregnancy. While we appreciate the agency’s attention to maternal mental health, we are deeply concerned that the panel included speakers who presented misleading or stigmatizing information about psychiatric treatment during pregnancy, undermined the scientific consensus, and failed to appropriately center the well-being of pregnant individuals.

    Misrepresentation and Ideological Bias

    Several panelists presented outdated or ideologically driven critiques of antidepressants rather than focusing on the panel’s intended topic: reproductive safety of SSRIs. When the context of pregnancy was discussed, claims of widespread harm were often based on studies that failed to adequately control for confounding by indication-that is, the underlying mental health condition for which the medication was prescribed. As Dr. Kay Roussos-Ross emphasized multiple times during the panel, more recent and methodologically rigorous studies that control for the presence and severity of depression have confirmed that earlier findings of harm no longer hold up when appropriate control groups are used. This reflects a central limitation of the existing literature: conflating the effects of medication exposure with the effects of untreated or undertreated psychiatric illness. While a few risks attributable to the use of SSRIs in pregnancy remain, the bulk of the evidence confirms that the risks of untreated illness generally outweigh the risks of medication use for those with moderate to severe depression.

    In contrast, the panel repeatedly cited findings of associations-such as congenital malformations or autism spectrum disorder- without clearly acknowledging the limitations of the studies behind these findings. Current data do not support a causal relationship between prenatal SSRI exposure and either congenital malformations or ASD. While SSRIs do influence serotonin pathways involved in early fetal development, biological activity is not the same as pathology. Many essential medications affect fetal physiology-what matters is whether that effect causes harm, and current data do not show that SSRIs cause sustained differences in developmental trajectories. Dr. Jay Gingrich clearly articulated this nuance during the discussion. He acknowledged that while SSRIs have theoretical effects on neurodevelopment, the evidence in humans has not demonstrated adverse outcomes in children exposed in utero. This remark reflected the kind of scientific humility and balanced interpretation that should guide these discussions. Unfortunately, other panelists relied on sensationalism and false equivalence. For example,

    • Dr. David Healy claimed SSRIs cause alcohol use disorder and suggested that if a medication causes birth defects, it implies that it also causes autism-none of which is supported by scientific consensus.
    • Additionally, he advocated using individual cases to make sweeping judgments about medication safety, which is the antithesis of public health science.
    • Dr. Jeffrey Lacasse invoked the outdated “chemical imbalance” theory to discredit SSRI use-a simplification irrelevant to current clinical rationale or safety in pregnancy.
    • Dr. Roger McFillin dismissed the value of scientific communication, stating that the public “doesn’t want graphs” and instead wants a to hear information from the heart – a deeply patronizing and dangerous claim that undermines the public’s right to clear, evidence-based information.
    • He also implied that women’s higher rates of depression reflect a “gift” of emotional sensitivity-a biologically uninformed view that disregards decades of research on reproductive hormonal transitions and their impact on mood. It also ignores the fact that reproductive hormones are neuroactive steroids with direct binding sites in the brain, influencing emotional regulation and stress response across the menstrual cycle, pregnancy, postpartum, and menopause.

    False Dichotomies.

    Multiple panelists framed care as a binary: SSRIs vs. lifestyle interventions. This is a false dichotomy. Clinical guidelines recommend SSRIs only when indicated and alongside additional evidence-based treatments and strategies like psychotherapy, physical activity, restful and adequate sleep, and social connection.

    The Other Side of Risk: Untreated Mental Illness

    Apart from the testimony provided by Dr. Kay Roussos-Ross, the panel largely failed to address the serious risks of untreated antepartum mood and anxiety disorders, which include:

    • Preterm birth and low birth weight
    • Poor prenatal care engagement and increased substance use
    • Increased risk of postpartum depression (untreated antenatal depression is the strongest risk factor for PPD)
    • Impaired maternal-infant bonding and attachment
    • Behavioral and emotional concerns in offspring
    • Suicide-a leading cause of maternal mortality in the U.S.
    • For a pregnant individual experiencing a major depressive episode or anxiety disorder, treatment decisions necessarily involve navigating risk. Discontinuation of mental health treatment during pregnancy, often due to fear or stigma, is a known factor in maternal suicides, as documented by multiple maternal mortality review committees. Public messaging that exaggerates the risks q(SSRIs while minimizing or ignoring the risks of untreated illness is not only misleading–it is dangerous.

    Reaffirming the Evidence-Based Role of SSRIs During Pregnancy

    While data informing SSRI use in pregnancy arc limited to retrospective, observational studies, these medications are among the most extensively studied in this population. When clinically indicated for moderate to severe depression or anxiety, SSRIs are recommended by the American College of Obstetricians and Gynecologists (ACOG), the American Psychiatric Association (APA), and the Society for Maternal-Fetal Medicine (SMFM).

    These medications are just one part of comprehensive, evidence-based mental health care. For many individuals-particularly those without access to psychotherapy-SSRIs may be the most effective and readily available option. Stigmatizing their use endangers patients and undermines providers.

    A Call for Inclusion in Research

    We acknowledge that observational studies have limits. The persistent exclusion of pregnant people from randomized controlled trials (RCTs) has left critical gaps in evidence. We urge the FDA and research institutions to invest in ethical, well-designed RCTs that include pregnant participants, so future decisions are grounded in science-not ideology.

    A Note of Appreciation for Scientific Integrity

    We are especially grateful to Dr. Kay Roussos-Ross for her clarity and clinical insight. As a physician trained in obstetrics and gynecology, psychiatry, and addiction medicine, she brought a uniquely informed perspective rooted in real-world care. She reminded the panel that SSRIs are not risk-free, but when used appropriately, they are low risk and often lifesaving. Her participation underscored the importance of reproductive psychiatry as a field, highlighting the need for experts who can translate evolving research into patient-centered, clinically grounded care.

    About NCRP

    The National Curriculum in Reproductive Psychiatry (NCRP) is dedicated to advancing the education of healthcare professionals in the assessment and treatment of psychiatric conditions during reproductive life events. Through standardized training and evidence-based resources, we aim to ensure that every person receives the mental health care they deserve before, during, and after pregnancy

    Reply

12. Dr. David Healy says

    July 24, 2025 at 7:32 am

    https://www.latimes.com/science/story/2025-07-23/fda-panel-on-ssri-antidepressants-in-pregnancy-raises-alarms
    Los Angeles Times
    FDA panel on the use of antidepressants during pregnancy is alarming experts
    Corinne Purtill Wed, July 23, 2025 at 11:00 AM GMT+1
    The U.S. Food and Drug Administration campus in Silver Spring, Md. (Andrew Harnik / Associated Press)
    The U.S. Food and Drug Administration is turning its attention to selective serotonin reuptake inhibitors, a class of antidepressant drugs long criticized by Health and Human Services Secretary Robert F. Kennedy Jr.
    On Monday morning, the FDA hosted a 10-person expert panel on the use during pregnancy of SSRIs, which include medications like fluoxetine (Prozac), sertraline (Zoloft) and citalopram (Celexa), among others.
    Nine of the panel’s 10 members were researchers, doctors or psychologists who have previously questioned the safety of SSRIs publicly or spoken out against antidepressant use in general.
    Over the course of the discussion, several panel members cited studies that lacked appropriate controls, physicians not involved with the panel said. In other words, there was no way to be certain on the basis of the studies whether the observed health problems were caused by SSRIs, the underlying mood disorder or some other factor.
    Other participants described study findings inaccurately or incompletely, said outside experts. For example, few panelists considered the risks of SSRI use relative to the risks associated with untreated depression, which also contributes to poor outcomes for children and mothers. In the U.S., suicide is a leading cause of maternal death in the first year of a baby’s life.
    An FDA spokesperson said the panel was part of the agency’s “broader efforts to apply rigorous, evidence-based standards to ingredient safety and modernize regulatory oversight” and did not respond to further queries about the agency’s potential next steps.
    But healthcare professionals expressed concern that the panel could ultimately prevent women from getting the care they need.
    “I was surprised and disappointed by the amount of misinformation that was presented,” said Dr. Katie Unverferth, a reproductive psychiatrist and medical director of UCLA’s Maternal Mental Health Program.
    “When we look at the body of data … we find that there are no consistent associations [of] SSRIs with cardiac defects, pulmonary hypertension or neurodevelopmental issues in offspring,” she said, naming some of the harms panelists attributed to the drugs. “This misinformation just creates intrusive thoughts. It’s not helpful.”
    The panel included just one specialist in maternal mood disorders — Dr. Kay Roussos-Ross, an obstetrician-gynecologist and director of the Perinatal Mood Disorders Program at the University of Florida College of Medicine — who argued that SSRIs are for most patients a safe treatment option for serious mental health disorders in pregnancy.
    “Mental health disorders are no different than medical disorders,” said Roussos-Ross.
    “I want to stress that treating mental illness in pregnancy is not a luxury. It’s a necessity,” she said. “We’re not asking [pregnant] women to not take their anti-hypertensives and risk death to them or their baby. We’re not asking women to stop their diabetes medications. We should not be withholding SSRIs as a possible treatment for women who need it.”
    The FDA did not respond to questions about how experts were selected for the panel. Participant Dr. Josef Witt-Doerring runs a private clinic that helps patients wean off psychiatric medication. Another panelist, Dr. Roger McFillin, is a prolific podcaster and a skeptic of germ theory, the belief — widely held as a fundamental truth in medicine since the 19th century — that infectious diseases are caused by microorganisms.
    Panelist Dr. David Healy, a psychiatrist from Wales, made a number of confounding and misleading statements, insisting that “mothers who are taking SSRIs in pregnancy have a 10-fold greater risk of having a baby with fetal alcohol syndrome” (that figure describes the subject population of a single 2011 study, not the general public). Healy also stated that “any drug that causes birth defects will cause autism spectrum disorder also,” a claim that has no basis in any scientific research.
    Dr. David Urato, chief of maternal and fetal medicine at MetroWest Medical Center in Framingham, Mass., was the only panelist besides Roussos-Ross who cares directly for pregnant patients. He spoke forcefully on the potential harms the drugs pose to developing babies.
    “Never before in human history have we chemically altered babies like this,” he said during the discussion. “There is now more than enough evidence to support strong warnings from the FDA about how drugs disrupt fetal development and impact the moms.”
    Roussos-Ross argued that the increased risk of birth defects for babies exposed to SSRIs in pregnancy was statistically insignificant, and that children of mothers with untreated depression were more likely to have later behavioral problems than those of mothers who took medication for the disease.
    “Having that [medication] not be available to women who need it would really be detrimental,” she said.
    At this, panel moderator Tracy Beth Høeg — a sports medicine doctor who is now a senior advisor for clinical sciences at the FDA — said, “I’m going to do something unconventional. I’m sorry to play favorites, but Dr. Urato, I want you to weigh in now.”
    In response, Urato questioned the idea that depression can be alleviated with antidepressant medication at all.
    “This idea about depression — [that it] can cause harm and therefore we treat [it] with these chemicals, and by getting the treatment we see improved outcomes — this is something we all would want. It’s wishful thinking,” he said. “But it’s not actually what the data shows.”
    It was not clear to which data he was referring. In 2019, the most recent year for which data are available, one in every eight U.S. adults had a prescription for antidepressant medication. While the drugs don’t work for all people with major depression, analyses of multiple studies have consistently found them to be significantly better than placebos at alleviating illness symptoms.
    The drugs have been a target of Kennedy’s Make America Healthy Again movement, along with vaccines and food dyes. In his confirmation hearings and on podcast appearances, Kennedy has claimed — inaccurately — that the drugs are both linked to school shootings and harder to quit than heroin. There is no evidence for either claim.
    In February, President Trump placed Kennedy at the helm of the Make America Healthy Again Commission, a group tasked with, among other things, evaluating “the prevalence of and threat posed by the prescription of selective serotonin reuptake inhibitors, antipsychotics, mood stabilizers, stimulants, and weight-loss drugs.”
    Healthcare professionals expressed frustration with the FDA’s approach.
    “There is already so much shame and stigma that surrounds these illnesses. There is also a lot of shame and stigma around taking medication during pregnancy or the postpartum period,” said Paige Bellenbaum, a perinatal mental health therapist and adjunct professor of social work at Hunter College. “We are taking a giant step backwards in so many ways. This will reinstill the fear that was there to begin with [and] will ultimately result in the loss of life.”
    Alexandre Bonnin, an associate professor of pathology at USC, has studied the effects of prenatal SSRI exposure on the developing fetal brain for years.
    The most recent large studies in the field haven’t found a statistically significant association between SSRIs and fetal harm, he said. “Our finding, at least at the basic science level, suggests that the use of SSRIs in pregnancy can be beneficial if the mom is under major stress, anxiety or depression, because the maternal stress actually itself has many negative effects on fetal brain development,” he said.

    Reply

13. Dr. David Healy says

    July 24, 2025 at 7:36 am

    https://www.raps.org/News-and-Articles/News-Articles/2025/7/FDA-panel-debates-label-change-on-SSRI-use-during
    FDA panel debates label change on SSRI use during pregnancy
    Regulatory News | 21 July 2025 | Jeff Craven
    A US Food and Drug Administration (FDA) panel convened on Monday to explore the impact of selective serotonin reuptake inhibitors (SSRIs) on fetal development, with some panel members proposing that the labeling for SSRIs be changed to include a warning about adverse maternal and fetal risks during pregnancy.
    At times, members of the FDA expert roundtable on SSRIs and pregnancy disagreed on the effectiveness of SSRIs in treating anxiety and depression, whether they should be used in pregnancy, and if mental health disorders should be treated with medication during pregnancy in the same way a physical problem like hypertension or diabetes would be treated.
    FDA Commissioner Marty Makary told those in attendance that as many as one in four middle-aged women are taking antidepressants, and up to 5% of women in pregnancy are on an antidepressant.
    While antidepressants can be an effective treatment for depression, “we have to stop and look at the bigger picture,” Makary said.
    “We are losing the broader battle of addressing mental health in the United States,” he said. “In some respects, we’re going backwards.”
    Makary claimed there has been a nationwide increase in depression as antidepressant use has increased, an increase in diabetes as insulin use has increased, and an increase in pain when pain medication use increased during the opioid epidemic.
    “I’m not suggesting that these medications—or any medications—are causative of mass explosions of these disease from an epidemic standpoint,” he said, “but we have to start talking about root causes.”
    Healthy relationships, community, natural light exposure, “other modalities and co-factors,” and novel therapies also need to be explored, he noted.
    Makary said the session was being convened because SSRIs may be unique due to serotonin interacting with maternal physiology and fetal organ development.
    “Serotonin may play a crucial role in the development of organs of a baby in utero,” including the heart, brain, and gut, Makary said. He also noted that some studies have linked SSRIs to cases of postpartum hemorrhage, pulmonary hypertension, cardiac birth defects, and “cognitive downstream effects in the baby.”
    Another issue stems from women on SSRIs not knowing they are pregnant and needing to wean off the medications during early pregnancy, Makary said.
    Informed decision-making

    Anick Bérard, of the University of Montreal and CHU Sainte-Justine, said depression and anxiety is very common during pregnancy, and needs to be treated “the same way we treat hypertension, diabetes, nausea, vomiting, and even migraine.”
    About 6% of pregnant women in the US and Canada take antidepressants, and most of them are SSRIs, Bérard noted. The incidence of anxiety and depression doubled at the beginning of the COVID-19 pandemic and has since decreased, “but is still widely prevalent,” she said.
    The use of SSRIs in pregnancy has been studied for over 30 years, Bérard said. Among antidepressants, paroxetine and fluoxetine have been linked with an increased risk of spontaneous abortion, congenital malformations, prematurity, low birth weight, cardiac defects, autism, and attention-deficit/hyperactivity disorder.
    Bérard acknowledged the situation is complex. Many women have mild or moderate symptoms of depression, there is no randomized controlled trial looking at the efficacy of SSRIs in pregnancy, and untreated depression and anxiety can increase the risk for postpartum depression.
    “The importance of informed decision-making in pregnant women is essential,” she said. “Pregnant women will be the ones making the decision, and they will be acknowledging the risks and the benefits for themselves if it is well explained to them.”
    SSRI exposure in utero
    Jay Gingrich, director of the institute for developmental sciences at Columbia University Irving Medical Center, discussed recent research from his group that found higher anxiety and depression symptoms in adolescents who were exposed to SSRIs in utero.
    “I like to think it’s reasonable to say that while SSRI treatment during pregnancy may improve maternal well-being, we haven’t yet found any evidence that it improves the outcomes of the offspring,” Gingrich said.
    “There may be evidence that it actually worsens the outcome, which is not something we would have expected,” he said.
    Nonpharmacological therapies such as psychotherapy and transcranial magnetic stimulation “can be extremely effective for mild-to-moderate depression and anxiety,” Gingrich said.
    Untreated anxiety, depression
    Kay Roussos-Ross, director of the perinatal mood disorders program at the University of Florida College of Medicine, said that unrecognized, untreated, and undertreated anxiety and depression can have a significant impact on maternal and fetal health as well as the health of the mother during pregnancy. These can include preterm delivery, preclampsia, small for gestational age infants, and increased risk for substance use and suicide, among others.
    “One of the leading causes of maternal death in the United States is mental health, including suicide and overdose deaths,” she said.

    Psychotherapy and SSRIs are “tools that we have in our armamentarium to make a positive impact in the lives of mothers and infants,” she explained.
    “Just like we would not withhold medications for preeclampsia, or medications for diabetes in pregnancy, or blood thinners in pregnancy when women have blood clots, we should not neglect treating mental health concerns,” Roussos-Ross said.
    FDA labeling
    Several panel members proposed changing the labeling on SSRIs to describe maternal and fetal risks associated with use during pregnancy.
    Adam Urato, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Mass., said he believes pregnant women “aren’t being properly informed on this issue, particularly with SSRI antidepressants.”
    “The public needs better information, and the FDA must strengthen the warnings,” he said.
    Urato said he thinks SSRIs should have a boxed warning describing maternal, fetal, and pregnancy complications.
    Josef Witt-Doerring, a psychiatrist at Taperclinic, said SSRI labels should be updated “to reflect what the science is showing.”
    “[T]he first part is getting the correct information in the label. The second problem is, how do we get it in a format that’s readily available and easily digestible so people can hear it,” he said.
    Roussos-Ross said there is “robust data” on SSRI exposure for hundreds of thousands of patients in different countries.
    “The panel has raised concerns related to SSRI use in pregnancy, but when we review the literature and account for the confounding variables, comparing patients with depression who are untreated versus patients who are with depression and medications, we actually see the risks are very similar between the two groups,” she said.
    More research needed
    Bérard said there are efforts from the Tri-Council in Canada and the Centers for Disease Control (CDC) in the US to safely include pregnant women in randomized controlled trials, but acknowledged “we might never have them.”
    If pregnant women were included in a randomized controlled trial, she said a study evaluating women with mild-to-moderate depression receiving SSRIs and women receiving psychotherapy or an exercise program “would be appropriate to do.”

    “Doing randomized controlled trials on pregnant women, I think, is something we should really look at,” Roussos-Ross said. “The physiology in women is different, the metabolism of drugs is different.”
    “Women are able to choose and should have the autonomy to choose if they would like to participate in research to further the field and to help other women as well, and to have the information that’s needed regarding the safety of meds,” she added.
    Meeting © 2025 Regulatory Affairs Professionals Society.

    Reply

14. David T Healy says

    July 25, 2025 at 8:22 am

    https://www.legalreader.com/fda-panel-questions-ssri-use-in-pregnancy/

    FDA Panel Questions SSRI Use in Pregnancy. Sara E. Teller July 24, 2025

    A recent discussion by a group of professionals selected by the FDA raised new concerns about how antidepressants known as SSRIs are being used during pregnancy. While these medications help many people manage depression, SSRI use during pregnancy remains a topic of debate. Panelists at the meeting spoke about the possibility that SSRIs might affect a baby’s development in the womb. These possible effects have been reported in some studies but are still not fully understood.
    The panel included doctors from different fields, including psychiatry, obstetrics, and psychology. Some of them have long questioned the benefits of SSRIs and have even compared them to placebos. Others said the risks to babies—including heart problems, lung complications, and behavior issues like attention disorders or anxiety—have not gotten enough attention. The challenge is that strong studies are limited, since pregnant women are usually not included in drug trials. Most of the current data comes from observational studies, which can show patterns but don’t always prove cause and effect.
    One doctor pointed out that the brain and body of a baby develop in ways that may be affected by serotonin, the brain chemical targeted by these medications. Other experts pointed out the need to consider how serious untreated depression can be during pregnancy. Leaving depression untreated can lead to early birth, lower birth weight, or other complications. Some mothers who stop their medication while pregnant may have a much higher chance of seeing their depression return. This can raise the risk of overdose, suicide, or poor connection with the baby after birth.
    Another panelist shared that nearly a third of babies exposed to SSRI use late in pregnancy may go through a condition that causes them to be shaky or fussy after birth. While the symptoms often clear up in a short time, the experience can be distressing for both the baby and the parents. Still, other studies have shown changes in brain activity in babies whose mothers took these medications while pregnant, though the long-term impact is unclear.
    Some on the panel asked the FDA to change the warning labels on these medications. They believe current information on drug packaging is not strong enough to help people understand the risks. One doctor even suggested adding QR codes on bottles that could lead patients to short videos explaining what they need to know in plain language.
    There was also disagreement among panelists about who should be giving this information. Some said it’s the job of the FDA to warn the public in more obvious ways. Others said the responsibility should fall on doctors, who can tailor the message to each patient’s situation.
    Alternative treatments like therapy or older antidepressants were brought up as other possible choices. A few speakers suggested that women may not need medications at all. One psychiatrist questioned whether antidepressants truly help most people and said the differences between drug and placebo are often small.
    However, not everyone agreed with this more skeptical view. One former FDA official warned that comments downplaying the value of SSRI use could cause panic. He said such claims might scare people away from getting help for a serious mental health problem. He also noted that many SSRIs have been well studied and found to be safe during pregnancy.
    The meeting ended without any formal rule changes, but it stirred debate about how depression in pregnancy should be handled. The biggest concern from many was making sure that pregnant women understand both the possible risks of medication and the real dangers of untreated depression. The topic remains complicated, with strong views on both sides and many unanswered questions about how best to support mothers and their babies.

    Sources:
    FDA Panel Takes Aim at SSRI Use During Pregnancy
    FDA panel promotes misinformation about antidepressants during pregnancy, psychiatrists say

    Legal Reader is devoted to protecting consumers. We take pride in exposing the hypocrisy of corporations, other organizations, and individuals whose actions put innocent people in harm’s way. We are unapologetic in our dedication to informing the public and unafraid to call out those who are more focused on profits than people’s safety.

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15. Dr. David Healy says

    July 25, 2025 at 3:36 pm

    Medscape Medical News
    https://www.medscape.com/viewarticle/fda-panel-casts-doubt-safety-ssri-use-pregnancy-2025a1000jq9

    FDA Panel Casts Doubt on Safety of SSRI Use in Pregnancy Dawn Attride July 25, 2025

    On Monday, July 21, a 10-member panel headed by Marty Makary, MD, MPH, commissioner of the FDA convened in Silver Spring, Maryland, to discuss the use of selective serotonin reuptake inhibitors (SSRIs) in pregnancy.
    In his opening remarks, Makary questioned the broader impact of antidepressant use, suggesting that increased prescribing may be contributing to — rather than alleviating — the burden of depression in the US.
    “We’re losing the broader battle of addressing mental health in the United States…the more antidepressants we prescribe, the more depression there is,” said Makary in his opening remarks.

    The majority of the panelists argued against SSRI use in pregnancy, citing potential risks such as altered fetal brain development, congenital cardiac malformations, and postpartum hemorrhage.

    The panel featured a range of perspectives, with several participants expressing concerns about potential risks associated with SSRI use during pregnancy.

    “Never before in human history have we chemically altered developing babies like this, especially the developing fetal brain. And this is happening without any real public warning,” said Adam Urato, MD, and chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Massachusetts.
    David Healy, fellow of the Royal College of Psychiatrists and CEO of Data Based Medicine, in North Wales, said that SSRI use during pregnancy is linked to autism and other neurodevelopmental disorders, citing his own 2016 review published in the International Journal of Risk & Safety in Medicine and unspecified animal studies.
    Other panelists questioned the overall effectiveness of antidepressants and expressed concern about the disproportionately high rates of SSRI prescriptions in women. Roger McFillin, PsyD, executive director of the Center for Integrated Behavioral Health, argued that some women’s emotional experiences are being pathologized, describing them as “gifts” rather than “symptoms of disease.”

    Leading Medical Organizations Respond
    However, leading medical organizations offer a different view. The National Curriculum in Reproductive Psychiatry (NCRP) noted in a release responding to the panel discussion that current data do not support a causal relationship between prenatal SSRI exposure and autism spectrum disorder.

    In a statement the American College of Obstetricians and Gynecologists (ACOG) stated that “robust evidence” shows SSRIs are safe in pregnancy and that most do not increase the risk for birth defects.
    ACOG pointed out that untreated depression in pregnancy can put patients at risk for substance use, preterm birth, preeclampsia, limited engagement in medical care and self-care, low birth weight, impaired attachment with their infant, and suicide.

    In its statement ACOG noted also that “for pregnant people who need SSRIs, they are life-changing and lifesaving” adding that “mental health conditions are already the most frequent cause of pregnancy-related death.” Furthermore, a 2023 ACOG practice guideline recommends SSRIs as first-line treatment for perinatal depression.

    Of the 10 panelists, Kay Roussos-Ross, MD, professor and director of the Perinatal Mood Disorders Program at the University of Florida in Gainesville, Florida, was the only one to emphasize the potential benefits of appropriately managed SSRI use during pregnancy and highlighted the serious risks associated with untreated perinatal depression.

    “Not every single woman will need an antidepressant. But for those that do, this is life changing. And this is lifesaving,” said Roussos-Ross, noting that one of the leading causes of maternal death in the US is mental illness.

    Call for Objectivity
    Roussos-Ross emphasized the importance of examining data objectively and accounting for confounding factors such as maternal depression. “All of us can find a study that agrees with exactly what we think,” she said. When such factors are controlled for, research shows adverse outcomes associated with SSRI use in pregnancy are attenuated.

    Panelist Jay Gingrich, MD, PhD, director of the Institute for Developmental Sciences at Columbia University Irving Medical Center in New York City, shared his latest research showing that children exposed to SSRIs in utero exhibited an overactive fear response compared with children whose mothers had lifetime depression but did not use SSRIs.

    Reached for comment ahead of the panel discussion, Gingrich, who has studied this topic for over 20 years, acknowledged the “unequivocal” evidence of untreated perinatal depression as a problem, but said “there is limited, or no, evidence that SSRI treatment of the mother improves outcomes of their offspring — at least at the population level.”

    Panelists called for SSRI labels to be consistent within drugs of the same class and to be updated to include the risks laid out in the panel discussion.

    Concerns Over Panel’s Claims
    Commenting for Medscape Medical News, Nancy Byatt, DO, MS, MBA, a perinatal psychiatrist and member of the American Psychiatric Association Council on Women’s Mental Health who attended the event, said much of the panel’s discussion was inconsistent with scientific evidence and clinical guidelines.

    She noted this “makes providing treatment much more challenging both for the providers serving patients and also for the patients who need the treatment themselves.”

    Also commenting on the discussion Sarah Nagle-Yang, MD, deputy executive director at Colorado Women’s Behavioral Health and Wellness and vice chair for quality at the Department of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, Colorado, who was not a participant but who attended the event, said that apart from Roussos-Ross, the panelists minimized the impact of perinatal mental health conditions.
    “I’m very worried that the goal of this was to stigmatize the use of antidepressants during pregnancy and to exaggerate the risk. I worry that it will result in outcomes such as a black box warning that will misrepresent the science and dissuade people from treating a treatable illness during a critical time of their life,” Nagle-Yang told Medscape Medical News.

    “Patients deserve honest communication that’s rooted in science, and I worry that this panel is moving us away from that goal,” she added.

    ‘Make Doctors Great Again’
    A core issue that panelists and outside experts agreed on was a lack of randomized controlled trials testing SSRI use in pregnancy.

    ACOG and NCRP advocated for the safe involvement of pregnant people in such trials. However, Roussos-Ross noted this current gap isn’t a reason to withhold SSRIs or other medications for which there is “robust observational data” from pregnant women.

    A frequent talking point was that doctors don’t properly inform their patients about the risks of SSRIs during pregnancy, in part due to time constraints and inadequate drug labels. “Make doctors great again,” said Healy, who claimed that physicians are increasingly relying on drug labels, not their experience to make prescribing decisions.

    In its release ACOG called it a “false accusation” that patients are deceived by doctors when it comes to the real effects of SSRIs.

    When asked about the panel’s intent and potential outcomes, a spokesperson for the FDA told Medscape Medical News that such discussions are part of the agency’s “broader efforts to apply rigorous, evidence-based standards to ingredient safety and modernize regulatory oversight, thoroughly considering evolving science and consumer health.”

    Medscape Medical News © 2025 WebMD, LLC
    Cite this: FDA Panel Casts Doubt on Safety of SSRI Use in Pregnancy – Medscape – July 25, 2025.

    Reply

16. David T Healy says

    July 25, 2025 at 6:46 pm

    https://slate.com/news-and-politics/2025/07/fda-rfk-ssris-panel-depression-pregnancy.html

    Slate said:

    Millions of Americans Need These Drugs. RFK Jr.’s Minions Have Them in Their Crosshairs.
    The FDA is promoting lies about medications people need—and starting their attack by targeting pregnant women.
    By Molly Olmstead July 25, 20255:45 AM

    Imagine you’re a newly pregnant woman struggling with depression and anxiety. Like many women in your situation, you have for years been on antidepressants, and you have questions about what your pregnancy means for your treatment. Imagine, then, you turn to the Food and Drug Administration for help, hoping that this government agency would present you with the best available medical science, and the leading experts on that science, as you try to navigate a complicated medical question.

    Under Health and Human Services Secretary Robert F. Kennedy’s revamped FDA, here’s what you get instead.
    A panel, convened Monday to “challenge or defend current dogma” surrounding antidepressants and pregnancy, featuring the British author of a book titled Pharmageddon, hammering the supposed link between antidepressants and autism; another British scientist, calling in from Europe, insistent that antidepressants actually have no effect on depression; the owner of a private “tapering clinic” that charges patients tens of thousands of dollars to guide them through quitting psychiatric medications, asserting women sometimes struggle for years to come off antidepressants; and an anti-vaccine podcast host who has spoken of the value of depression as an “emotional experience.”

    The panel focused specifically on SSRIs, or selective serotonin reuptake inhibitors, the specific category of drugs being debated. Common SSRIs include Prozac, Lexapro, and Zoloft, and they’re the most widely prescribed form of antidepressant in the U.S. According to the Cleveland Clinic, more than 1 in 10 Americans take some kind of antidepressant.

    Of the 10 panelists, only one—the sole specialist in maternal mood disorders at the event—argued for SSRIs’ safety and value. The others insisted, with just as much of a sense of authority and certainty, that the medications were ineffective and that they caused miscarriages, hemorrhaging, autism, ADHD, cardiac birth defects, fetal alcohol syndrome, and other frightening outcomes.

    For any pregnant woman tuning in or later hearing about the two-hour conversation, it would be hard to come away without a sense of confusion and anxiety about taking antidepressants.
    Here’s the bottom line on pregnancy and antidepressants, according to that best available science and the experts on it: The risks of failing to treat an expecting mother’s depression far outweigh any risks from the medication itself.

    The question of how SSRIs can affect pregnancy, childbirth, and fetal development is a complicated one that scientists believe deserves continued research and discussion. There are a few studies that show very rare risks of certain complications from SSRIs in pregnancy. And there is a more common condition in which babies become jittery, irritable, or have difficulty with sleeping or eating in the first few days after birth. Still, SSRIs are some of the most heavily studied medications for pregnant women, and the consensus is that they are safe.

    “Robust evidence has shown that SSRIs are safe in pregnancy and that most do not increase the risk of birth defects,” the president of the American College of Obstetricians and Gynecologists said in a statement responding to the panel. “Unfortunately, the many outlandish and unfounded claims made by the panelists regarding SSRIs will only serve to incite fear and cause patients to come to false conclusions that could prevent them from getting the treatment they need.”

    On the FDA panel, however, the discussion essentially buried that expert consensus under a barrage of misinformation, speculation, conspiracist theorizing, and pseudoscience. “Expertise” was a thing to be mistrusted, and the most qualified member of the panel—whose views reflected the scientific consensus—was both outnumbered and given no more weight than anyone else.

    In RFK Jr.’s America—where the “Make America Healthy Again” movement is ascendant—the people deemed worth listening to are loud, angry, and confidently deluded.

    According to the American College of Obstetricians and Gynecologists, mental health conditions are the most common cause of “pregnancy-related death,” largely because of overdoses, alcohol abuse, and suicide. But depression is still an issue for less extreme scenarios. Stress is known to be difficult on pregnancies—the ACOG statement mentioned depression putting patients at risk of preterm birth, preeclampsia, and low birth weight—and depression can often prevent pregnant women from getting proper medical care. Studies also show babies with mothers who struggle to bond can have developmental delays.

    Instead of laying out the pros and cons with an explanation of the analytical methods by which the medical research community reached its current consensus, the FDA panel instead presented “world-renowned experts” who spoke only of alleged risks of SSRIs—risks based on flawed studies—and cast doubt on depression itself as a matter for medical concern. With just one voice of dissent on the panel, it seemed that the world’s experts were mostly in agreement that SSRIs were definitively dangerous. By mainstreaming fringe skeptics of modern medicine, the FDA clouded what has been, until this point, a clear consensus on the ultimate value of these medications.

    This was something the FDA didn’t just platform but actively encourage: When the panel’s single pro-SSRI speaker argued that depression actually posed a greater threat to pregnant women and new mothers, the moderator called on one of the other panelists to respond because “you two have two very different points of view, and you’re both physicians”—portraying the two figures as being equally qualified to weigh in, even as the second actively spreads misinformation on social media about SSRIs’ link to autism.

    The panel was part of Kennedy’s broader campaign to challenge SSRIs: FDA panels are indicators of where policy is likely to go. Kennedy, the secretary of Health and Human Services, sees them as a major symbol of the country’s overmedication. He also holds unscientific views of the drugs, having falsely claimed in the past that there is a link between antidepressants and school shootings and that they are more difficult to quit than heroin.

    And in line with that broader mission, the misinformation went beyond the notion that SSRIs caused health issues in pregnancies, in ways that spoke to the instincts of the MAHA movement. One of the two British panelists, psychiatrist Joanna Moncrieff, used her time on the panel to emphasize that there was no evidence SSRIs did patients any good. Instead, she argued, they “alter” patients’ brain function akin to the way alcohol or opioids do, rather than helping with any underlying issue. This “emotional numbing” wasn’t actually helping anyone, she said. Similarly, David Healy, the other British psychiatrist, argued that depression should not be treated as a medical issue of concern because people tend to “recover spontaneously” from depressive episodes in a matter of weeks.

    This approach to thinking about depression fits with the MAHA movement’s ideas about health and mental wellness. Typically, the doctors in this movement emphasize a “natural” approach to handling mood disorders, rather than an overly “medicalized” one. This approach emphasizes individual responsibility to improve your own mental well-being through exercise, diet, and self-empowerment—and, when that fails, learning to embrace the misery.

    As one panelist, Dr. Roger McFillin, put it: “You’re describing emotional experiences. What has happened when we’ve medicalized all aspects of the human experience?”

    McFillin, a psychologist in Bethlehem, Pennsylvania, argued that treating depression as an illness actually causes greater human suffering because it causes people to doubt their “own internal experiences” rather than learn from them. “Does anyone here believe that we evolved to feel pain and emotional distress, and that’s somehow a flaw in our genetic evolution?” he asked the panel. “I want to challenge people to have a different discussion, to see everything you experience as a signal, and a very important signal that if you don’t learn to pay attention to, you’ll surrender your autonomy … and you’re going to be dependent on the medical system.”
    He then hit on another MAHA theme: a particularly reverent and patronizing idea of womanhood. Why, he asked, do women take SSRIs at a higher rate than men? Is it because women are more mentally ill? “Or are women just naturally experiencing their emotions more intensely?” he said. “And those are gifts.”

    One key part of all these arguments is in the empowerment of the individual to take hold of their health—if they purchase the right homeopathic products, follow the right health influencers, or buy the right nutrition plans. They sell the notion of willpower and changing your thinking. It’s an individualistic approach utterly at odds with the population-level thinking of public health. And in that individualized approach, taking control of your own medical care means cutting out doctors—and therefore their medicines—who are products of a system in which patients are, necessarily, dependent on the doctor’s expertise. That leaves more basic solutions: diet, exercise, and strange, untested remedies.

    Of course exercise, diet, self-empowerment, and other non-medicinal factors have a role in alleviating depression. But that’s reflected in the medical consensus, which recommends those things as a complement to tested and proven psychiatric treatments. And of course there’s room for humans to experience a full range of emotion, but that’s different from the medically dangerous condition of depression, which does not necessarily emerge as a response to a hardship and which can cause people to function poorly in day-to-day life. This kind of state of existence, in which it can be impossible to experience joy or interest in your favorite things, is one few would describe as healthy, much less a “gift” to women.

    The experts the FDA brought in for its panel weren’t just any kind of SSRI critics. They were, in large part, people who had built personal brands around speaking “truths” about the institutions they operated in—or at the fringes of. And speaking at the FDA was not just a matter, for these figures, of challenging conventional dogmas, but of boosting their own reputations, sometimes to the benefit of their own finances and audiences.
    McFillin hosts a podcast called Radically Genuine, in which he argues against mainstream psychiatric practices. Some of his episodes have dealt with a “vaccine-injured” doctor; detransitioners and the harm of transgender-affirming medical care; telepathy; and the “GERM THEORY LIE.”

    He’s not the only podcaster of the group. Josef Witt-Doerring, the psychiatrist with the “tapering clinic” and a former FDA official, has 140,000 subscribers on YouTube. He has made videos about “The Benzodiazepine ‘Holocaust’ ”; “SSRI-Induced ‘Suicide’ ”; and the “10 MOST Dangerous Prescription Drugs.” The exchange of podcast appearances among this group is tight. Witt-Doerring hosted Moncrieff, Healy, and McFillin, as well as another panelist, Dr. Adam Urato, an obstetrician-gynecologist in Framingham, Massachusetts. McFillin hosted Urato. Urato and McFillin have both gone on the podcast hosted by Allie Beth Stuckey, a very popular right-wing influencer, to talk about the dangers of SSRIs. Joe Rogan has promoted several of the panelists.

    What makes these communicators effective in the MAHA media space is not just their message, but how they go about delivering it. In the MAHA world, what matters more than studies and data is what feels right, especially if you don’t have a medical degree. It’s an accessible form of argumentation for the public, and one that encourages people to think about their own health with common sense and instinct.

    When McFillin introduced himself at Monday’s FDA panel, he announced that the “public does not want to look at graphs or meaningless statistics” and said he would instead “speak from the heart.” Urato appealed to “common sense” when discussing the dangers of SSRIs, telling people to just “think about it”: “Chemicals have consequences.”

    The simplicity of the message is appealing. As is the framing of their arguments as big, bold ideas that upend everything you know. If depression isn’t really a problem, if mental health isn’t a medical issue, if the entire way scientists claim to understand chemicals in the brain is all wrong, then maybe you should step away from the system entirely.

    There’s a darker element of their argument, as well. In the panel, several speakers made the reality out to be quite frightening. “Never before in human history have we chemically altered babies like this,” Urato said at one point. Several emphasized that information was being kept from patients, who deserved full understanding of the risks of SSRIs in order to make informed decisions.

    But if there was one underlying message of the FDA panel, it was not about SSRIs but about the system more broadly. It wasn’t just that this particular medical scenario needed more research; it was that the entire medical system was held captive by a villainous pharmaceutical industry, which actually sponsored the studies into SSRIs and pregnancy. No medical institutions could be trusted. It all came down to profit-making moves and advertising.

    “The social reputation of these drugs as normalizing agents, akin to giving vitamin C in a case of scurvy, basically, is essentially a promotional message that our entire society has adopted,” the panelist Jeffrey Lacasse, an associate professor at Florida State University’s College of Social Work, said at one point.
    These were, in other words, classic MAHA doctors, using classic MAHA lines of reasoning. It’s not clear how the FDA selected these particular figures to be on their panel, but it’s unlikely there was anything unexpected in what they said, given that the panelists had all spoken so publicly of their unorthodox views in other media. The FDA invited them onto a stage where, the moderators said, they hoped they would feel “uninhibited” to “challenge or defend current dogma.”

    But there was one telling piece of context that showed just the real thinking behind the panel. As doctors who support SSRIs have said, the drugs do need more research in controlled studies with pregnant women. So far, partly because of ethical issues, but also partly because pregnant women are not often prioritized in medical research, there have been no randomized controlled trials of SSRIs in pregnant women. The American College of Obstetricians and Gynecologists has called for these to be done. As did the one pro-SSRI member of the FDA panel. According to the ACOG statement, the FDA had planned a working group on research on SSRIs in pregnancy, but because of the Trump administration’s cuts to the National Institutes of Health, that work has stalled. In a scenario in which the government sought better data on this medical question, the administration cut off the funding—and sent conspiracy theorists to talk about it instead.

    Reply

17. David T Healy says

    July 25, 2025 at 8:20 pm

    https://www.psychiatry.org/getattachment/dd143827-be33-42ab-8f48-69b9dff5dff8/APA-Letter-FDA-Panel-SSRIs-Pregnancy-07252025.pdf

    July 25, 2025 Commissioner Marty Makary, M.D., M.P.H. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

    Dear Commissioner Makary,

    On behalf of the American Psychiatric Association (APA), the largest medical specialty society representing more than 39,200 physicians who specialize in the treatment of mental illnesses, including substance use disorders, we appreciate the agency’s attention to maternal mental health. However, we are alarmed and concerned by the misinterpretations and unbalanced viewpoints shared by several of the panelists for the Expert Panel on Selective Serotonin Reuptake Inhibitors (SSRIs) and Pregnancy panel on July 21st. This propagation of biased interpretations at a time when suicide is a leading cause of maternal death within the first postpartum year could seriously hinder maternal mental health care. The inaccurate interpretation of data, and the use of opinion, rather than the years of research on antidepressant medications, will exacerbate stigma and deter pregnant individuals from seeking necessary care.

    Mood and anxiety disorders occur in one in five pregnancies, yet they remain largely undiagnosed, untreated, or undertreated. Suicide is a major cause of mortality for women in the perinatal period, accounting for 5–20% of maternal deaths.1 In 2023, APA released a perinatal mental health toolkit that includes a white paper and factsheets for patients and providers to ensure that informed and transparent care can be provided to individuals at this stage in life.2 The results of the literature review for the white paper show an association between unmanaged perinatal mental health problems and adverse outcomes for pregnant individuals and fetus/child, including increased morbidity and mortality.3 Research shows the risk to the mother and child from untreated mental health disorders may lead to harmful outcomes.4 This underscores the need for widespread and standardized screening practices with validated tools such as the Edinburgh Postnatal Depression Scale (EPDS), the Patient Health Questionnaire (PHQ-9), and the Generalized Anxiety Disorder-7 (GAD-7), and a greater commitment by the field to developing and implementing perinatalspecific prevention and treatment initiatives.

    The overall evidence suggests that individuals can and should take SSRIs prior to or during pregnancy, when they are clinically indicated for treatment. Moreover, recent meta-analyses have found no association between prenatal SSRI exposure and overall risk of birth defects.5 The analysis goes on to say that some concerns with specific SSRIs have emerged. These should be individually addressed between the patient and physician to partner in decision making ensuring the best outcomes for the patient and the fetus, as is the case for any drug. Physicians should also work closely with patients to assess the risks and benefits of psychopharmacotherapy and monitor for potential side effects, ensuring each patient receives individualized care. The American College of Obstetricians and Gynecologists (ACOG) Guidelines on Psychiatric Medication Use During Pregnancy and Lactation are widely used by physicians to treat perinatal and pregnant individuals, and it states, “Treatment with SSRIs or selective norepinephrine reuptake inhibitors during pregnancy should be individualized.”6 ACOGs guidelines also strongly recommend against withholding or discontinuing medications for mental health conditions due to pregnancy or lactation status alone.7 Psychiatric medications are safe, effective, and can be lifesaving if they are taken properly — as directed –under the care of an appropriately licensed healthcare professional.

    The dissemination of inaccurate and unbalanced information by a federally sanctioned public panel has the potential to cause harm. It can undermine public confidence in mental health treatment, exacerbate stigma, and deter pregnant individuals from seeking necessary mental health care. We urge the FDA to review the composition and scientific rigor of its expert panels, particularly those influencing public health messaging. We also urge the FDA to re-evaluate the research that was presented to ensure that a true risk benefit analysis happens prior to any actions taken by the FDA.

    The FDA has a duty to ensure that its public health guidance is rooted in science and transparency. As the largest organization worldwide for psychiatric physicians, we would like to partner with your agency to inform your policy decisions and to educate the public on the treatment of maternal mental health disorders. Many of our physician members have devoted their careers to exclusively taking care of women with maternal mental health conditions, often caring for thousands of patients a year, and are uniquely poised to provide you and your team accurate and balanced information. If we can be of further assistance, please contact Kristin Kroeger, Chief Advocacy, Policy, and Practice Advancement, at kkroeger@psych.org.
    Sincerely,
    Marketa Wills, MD, MBA, FAPA
    CEO and Medical Director American Psychiatric Association

    1 Davis, N. L., et al. (2019a). Pregnancy-Related Deaths: Data from 14 U.S. Maternal Mortality Review Committees, 2008- 2017. Atlanta, GA, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services
    2 American Psychiatric Association, Perinatal Mental Health Toolkit, 2023, https://www.psychiatry.org/psychiatrists/practice/professional-interests/women-s-mental-health/maternal-mental-health-toolkit
    3 Clarke DE, De Faria L, Alpert JE, The Perinatal Mental Health Advisory Panel, The Perinatal Mental Health Research Team. Perinatal Mental and Substance Use Disorder: White Paper. Washington, DC: American Psychiatric Association; 2023 [Available from: https://www.psychiatry.org/maternal%5D.
    4 Clarke DE, De Faria L, Alpert JE, The Perinatal Mental Health Advisory Panel, The Perinatal Mental Health Research Team. Perinatal Mental and Substance Use Disorder: White Paper. Washington, DC: American Psychiatric Association; 2023, page 49 [Available from: https://www.psychiatry.org/maternal%5D.
    5 Clarke DE, De Faria L, Alpert JE, The Perinatal Mental Health Advisory Panel, The Perinatal Mental Health Research Team. Perinatal Mental and Substance Use Disorder: White Paper. Washington, DC: American Psychiatric Association; 2023, page 49 [Available from: https://www.psychiatry.org/maternal%5D.
    6 American College of Obstetricians and Gynecologists Guidelines on Psychiatric Medication Use During Pregnancy and Lactation, 2008, Am Fam Physician. 2008;78(6):772-778, found at: https://www.aafp.org/pubs/afp/issues/2008/0915/p772.html
    7 American College of Obstetricians and Gynecologists Guidelines on Psychiatric Medication Use During Pregnancy and Lactation, 2008, Am Fam Physician. 2008;78(6):772-778, found at: https://www.aafp.org/pubs/afp/issues/2008/0915/p772.html

    Reply

18. Dr. David Healy says

    July 26, 2025 at 12:55 pm

    Stat covered the panel hearing as follows:
    An unusual FDA panel on antidepressant use during pregnancy elevated skeptics of the drugs
    By Lizzy Lawrence July 25, 2025 FDA Reporter

    Intrusive thoughts and panic attacks plagued Tinelle Windham throughout her first three pregnancies. During her second, a doctor recommended she start taking Zoloft, a type of antidepressant called a selective serotonin reuptake inhibitor, or SSRI. But she was wary. What about side effects? What if it harmed her baby?

    “I really was leery of getting it treated that way, and I saw a therapist for a small amount of time, but mostly I just toughed it out,” said Windham, a lawyer living in southern Maryland. “It was a very terrible experience trying to tough it out.”

    Toughing it out is a common approach among pregnant people with anxiety and depression. Many choose to avoid or go off antidepressants out of fear that the medications will harm their developing babies.

    But the risks of untreated mental illness, especially during pregnancy, are serious, and tend to outweigh the small and uncertain risk of antidepressants harming unborn babies, experts told STAT. Mental health conditions, including suicides and drug overdoses, are now the leading cause of pregnancy-related deaths, according to a 2024 report from the Centers for Disease Control and Prevention.

    If you tuned into a recent discussion hosted by the Food and Drug Administration on the effects of SSRIs during pregnancy, however, you would have heard a different story, one overwhelmingly focused on the treatments’ risks. That seemed to be by design. Rather than recruiting a wide range of experts to discuss the best data available, the administration mainly invited clinicians and researchers who have a record of deep skepticism of antidepressants, including some who financially benefit from that skepticism.

    It’s the latest in a series of expert panels convened by FDA Commissioner Marty Makary and other leaders at the agency. Some panels correspond to a policy area the administration has prioritized, like infant formula. Others have focused on questions Makary has taken a personal interest in, like hormone replacement therapy in menopause, a topic he wrote about in his book “Blind Spots.”

    The panels are unusual because they’re being planned very quickly, and with little input from career staff. Unlike traditional advisory committees, it is unclear how the FDA is selecting panelists and whether it is screening them for conflicts of interest. There are no briefing documents brimming with data. Often they’re dominated by experts who share Makary’s tendency to question mainstream medical practices.
    And in most cases, it’s not clear how the FDA plans to use input from the panels to change policy or guidelines.

    “The claim that the FDA’s expert advisory process is ‘one-sided’ or politically driven is insulting to the independent scientists, clinicians, and researchers who dedicate their expertise to these panels,” an FDA spokesperson told STAT.

    The SSRI panel was planned and moderated by Tracy Beth Høeg, a top official in the commissioner’s office who has also played a role in limiting the FDA’s approval of Covid-19 vaccines. Most of the panelists expressed a common view, one that’s not supported by the weight of medical evidence: Antidepressants are harmful to developing babies, and the FDA should do more to tell women about their risks.

    One panelist, a psychologist and podcaster named Roger McFillin, suggested that depression is not a “discrete condition that we can identify.” He said women might just be experiencing their emotions more intensely while pregnant. “Those are gifts,” he said. “They’re not symptoms of a disease.”

    Others pointed to animal and laboratory studies suggesting SSRIs harm fetuses, rather than observational studies that have enrolled millions of pregnant women over the years. There was just one epidemiologist and one maternal mental health specialist among the 10 panelists, seven of whom were men.

    “I think [the FDA] can say things like when we gave these medications to rats, we noticed autistic-like behavior and decreased mating when they grew up,” said Josef Witt-Doerring, a psychiatrist who runs a clinic designed to help people taper off SSRIs and who spoke on the panel. “It’s not in humans, but that’s concerning enough.”

    But five experts STAT spoke to, who study maternal mental health, epidemiology, or birth defects, were far more concerned about the perils of untreated depression. They worried that the FDA disproportionately featuring people who sow doubt about antidepressants will scare pregnant people into stopping treatment entirely.
    “The absolute risk of birth defects is very small,” said Sura Alwan, a birth defects epidemiologist at the University of British Columbia. “What’s dangerous is creating fear that leads people to stop treatment abruptly or avoid care entirely.”

    What do we know about SSRI use during pregnancy? Doctors have less information to work with when prescribing medication to pregnant women, generally speaking, because they are frequently excluded from randomized trials testing the safety and efficacy of drugs.

    Instead, to figure out how antidepressants may affect pregnant women and babies, experts rely on observational studies tracking the outcomes of large groups of people. They typically compare those who took antidepressants and those who did not.

    The approach is challenging, because it can be hard to account for differences between those groups, and even for the underlying effects of depression or other conditions that may prompt people to take medicine in the first place. SSRIs, as the most commonly prescribed antidepressants, have been studied the most.

    Some studies have shown a slight increase in risk for heart defects in infants, one of which led the FDA to advise pregnant women to avoid the drug Paxil in 2005. And recent, better studies that account for underlying factors like the depression itself have shown no difference in this risk between mothers taking SSRIs and those who aren’t.

    “One of the challenges is that the illness itself also causes risk,” said Nancy Byatt, a perinatal psychiatrist at the University of Massachusetts. “That is very hard to tease out in these studies.”

    Sometimes babies whose mothers took SSRIs are initially fussier or more irritable. This is called neonatal adaptation syndrome, and affects about 25%-30% of infants exposed to SSRIs later in pregnancy. Experts told STAT this behavior goes away on its own as infants get used to not receiving the medication.

    The possibility of SSRIs causing autism or other long-term developmental issues came up frequently at the panel, but the research is muddy.

    “The best evidence we have suggests that the association with SSRIs may not be causal at all,” Alwan said. “It likely reflects shared familial or genetic factors.”

    It’s possible that SSRIs raise the risk of preterm birth and postpartum hemorrhage for the mother; those risks did not come up at the panel. But in general, researchers have not detected clear, major risks associated with SSRI use during pregnancy, for either mothers or babies.

    What’s abundantly clear is the risk of unaddressed depression. Pregnant women with depression are more likely to abuse substances or to have suicidal thoughts. The illness can affect their children as well, impacting development and behavior.

    Sierra Stone, a state parole officer in Erie, Pa., is pregnant with her third child. She’d gone through her first two pregnancies without medication, all the while tormented by an inner monologue telling her she was inadequate, or that her children would be better off without her.

    Three years ago, her psychiatrist prescribed an antidepressant. But when she became pregnant, she worried the medication would affect the baby, especially after her psychiatrist told her he was no longer comfortable treating her.

    Stone stopped her meds and, almost immediately, the depression symptoms came back. She set up an appointment with a perinatal psychiatrist, who told her to go back on her medication at a lower dose.

    “Two weeks ago, I spent an entire weekend uncontrollably crying,” Stone said. “I just couldn’t get out of bed. It was at that moment that I was like, I need help.”

    Doctors do like to suggest therapy first to treat mild cases of depression in pregnant people, because any medication comes with risks. But if depression or anxiety symptoms are severe, SSRIs are warranted, experts said.

    “When someone has untreated illness, it’s an exposure in itself that we want to minimize,” Byatt said.
    In a recent conversation with journalist Megyn Kelly, Makary said the goal of the FDA’s expert panels is to encourage scientific discourse and debate. He said he wants to bring together people from opposite sides of an issue, and, by contrast, criticized regulators during Covid as a “homogenous group of like-minded friends.”
    The experts who gathered at the FDA’s Silver Spring, Md., campus on Monday looked a lot like a group of like-minded friends.

    Nine out of 10 panelists have either been paid witnesses in litigation involving antidepressants, run media platforms rooted in SSRI skepticism, or have published research pointing to the drugs’ potential risks in developing babies. Many share the views of health secretary Robert F. Kennedy Jr., who has called SSRIs harder to quit than heroin and has falsely linked them to mass shootings.

    Adam Urato, a maternal-fetal medicine doctor at MetroWest Medical Center, is a longtime skeptic of the drugs and has called them harmful chemicals. Witt-Doerring, the psychiatrist at TaperClinic, runs a YouTube channel encouraging people to stop taking their SSRIs. McFillin’s podcast raises doubts about the value of psychiatric diagnoses and medications; both Urato and Witt-Doerring have been guests.

    Several have been paid to testify in litigation involving antidepressants, including Anick Bérard, a professor of perinatal epidemiology at the University of Montreal. In a 2014 case against Pfizer’s Zoloft, a Pennsylvania judge rejected her testimony due to methodological errors. Bérard also published a paper in 2016 reporting a possible link between SSRI use during pregnancy and higher rates of autism.

    Michael Levin, a biologist at Tufts University, has also been an expert witness for plaintiffs in cases involving SSRIs. He studies the effects of serotonin on fetal development. David Healy, too, has assisted plaintiffs in litigation involving antidepressants and wrote a book claiming that the side effects of SSRIs are worse than depression itself.

    Others have published research chipping away at the credibility of SSRIs and the companies that make them. Joanna Moncrieff, a psychiatrist at University of College London, is critical of antidepressants and the serotonin-chemical imbalance theory underpinning SSRIs. Jay Gingrich, a developmental psychologist at Columbia, ran studies showing that SSRIs increased anxiety in mice offspring. Jeffrey Lacasse, a social worker at Florida State University, has written about biased antidepressant advertising.

    Kay Roussos-Ross, the director of the Perinatal Mood Disorders Program at the University of Florida, was the sole expert on the panel without a skeptical background. She and Bérard often chimed in during the event to draw attention to the risks of untreated depression.

    “Based on the current literature that we have, that is agreed upon by many professional societies, the risks of untreated mental health conditions are significant and SSRIs should be considered as one of the treatment options with informed decision-making,” Roussos-Ross said during the panel.

    Bérard told STAT after the panel she was concerned that the conversation did not adequately convey the risks of not treating depression and anxiety during pregnancy. The decision to prescribe SSRIs might be different for each individual, she said, depending on the patient’s trimester, severity of depression, or whether they were already taking the medication.

    “There is some risk associated with using SSRIs and pregnancy, but there are also risks associated with non treatment,” Bérard said. “It’s a balancing act, and it’s complex, and the risk benefit assessment can very well differ.”

    Roussos-Ross told STAT the FDA invited her to speak a week before the event. By contrast, Bérard said the FDA reached out about a month prior. The FDA did not answer any of STAT’s questions about the planning and makeup of the panel.

    Because of the imbalance in viewpoints, the potential risks of SSRIs got a lot of airtime. The panelists repeatedly suggested that psychiatrists are hopelessly conflicted by industry interests, and thus have a stake in prescribing as many SSRIs as possible. They claimed that the FDA and doctors should do more to warn pregnant people of their risks, mostly pointing to studies that weren’t done in people.

    The FDA’s YouTube stream of the panel had been watched more than 8,000 times as of Thursday. Experts told STAT it’s healthy to have some skepticism of medications, but the skewing and misrepresentation of data could end up harming mothers who desperately need treatment, and their children.

    After the event, the American College of Obstetricians and Gynecologists called the panel “alarmingly unbalanced.” The Society for Maternal-Fetal Medicine said it was “alarmed by the unsubstantiated and inaccurate claims.” Both groups support the use of SSRIs to help treat depression during pregnancy.

    It took Windham, a self-described conservative and Christian, years to acknowledge how deep her mental health struggles were during pregnancy. After her third pregnancy, she decided to listen to her doctor and start taking Zoloft. Her fourth and most recent pregnancy went smoothly.

    “I care so much about the unborn that it took a lot of soul-searching to prioritize my mental health,” Windham said. She urged the FDA to consider the health of the mother, too.

    What will the FDA do now?

    There are generally two types of public FDA meetings. There are public hearings, where FDA staff and researchers present on a topic and then solicit input from stakeholders. There are also advisory committees, where the FDA seeks advice from vetted, independent experts on what regulatory action to take based on new evidence. That new evidence is posted online for the public to review.

    “Ordinarily they would be catalyzed by some sort of new information that raises questions,” said Eva Temkin, a former FDA lawyer now working with industry clients at Arnold & Porter. “By new information, I mean new scientific information, not new politics.”

    The FDA’s expert panels thus far have not revolved around new safety or efficacy data, nor have they solicited concrete advice on specific actions the agency should take to better regulate these products. Three former FDA lawyers told STAT the agency could open itself up to litigation if it acted based on information shared at one of these panels, since the selection of experts wasn’t transparent.

    “It’s sort of a gray area,” said Claire Davies, a former FDA attorney now working with industry clients at Polsinelli. “From the outside, we don’t know exactly how the information from these panels is getting used.”
    The FDA wouldn’t comment on future regulatory actions. But Makary told Kelly the agency might use the expert panel’s advice to beef up warnings for pregnant women on the labels of SSRIs. He said the reason for convening the ad hoc panel rather than a regular advisory committee was to “work at real person speed.”

    “Should [a warning] be on the label of more, even if we don’t have data?” Makary said. “Should we err on the side of safety? That’s exactly why we’re convening experts.”

    Reply

19. Dr. David Healy says

    July 27, 2025 at 6:00 pm

    National Public Radio said the following:
    https://www.npr.org/2025/07/27/nx-s1-5477532/an-fda-panel-spread-misinformation-about-ssri-use-in-pregnancy-doctors-are-concerned

    Reply

20. David T Healy says

    July 30, 2025 at 8:48 am

    Scripps – or maybe A.I. – is reporting the story as follows:

    https://www.msn.com/en-us/health/other/fda-weighs-warning-labels-on-antidepressants-for-pregnant-women-despite-safety-consensus/ar-AA1Jwqiq?ocid=BingNewsSerp

    FDA weighs warning labels on antidepressants for pregnant women despite safety consensus
    Story by Scripps News Group

    The Food and Drug Administration is considering adding warning labels to antidepressants for women who are pregnant, despite medical consensus that these medications are safe.

    The agency convened an advisory panel on July 21 that included six professors from various universities, a psychiatrist from a clinic that speciailizes in getting patients off of psychiatric medications, a clinical psychologist, the chief of maternal-fetal medicine at MetroWest Medical Center in Massachusetts and the founder and CEO of Data Based Medicine in North Wales, which operates a website where patients directly report the effects of drugs.

    Most of the members of the panel have a longstanding history of being outspoken against the use of psychiatric medications.

    “From a national standpoint, the more antidepressants we prescribe, the more depression there is,” said FDA Commissioner Dr. Marty Makary without providing evidence for that claim.

    He said the panel was brought together because it believes serotonin may play “a crucial role in the development of organs of a baby in utero,” and that they believe other methods of depression treatment, such as “healthy relationships” and “natural light exposure” should be explored.

    “And one of the unique issues in pregnancy is sometimes you don’t know that you’re pregnant in the first trimester of pregnancy, and it takes time to wean off some of these antidepressants like SSRIs,” Makary added.
    SSRIs, or selective serotonin reuptake inhibitors, are a class of drugs that are some of the most commonly used antidepressants, such as Zoloft, Lexapro and Prozac.

    The advisory panel proposed warning labels over concerns about potential risks of autism, miscarriage and birth defects that they claim are tied to the use of SSRIs during pregnancy.

    According to Johns Hopkins, antidepressants are not known to cause birth defects. However, about 30% of babies born to mothers taking antidepressants develop a condition called neonatal adaptation syndrome, which can cause jitteriness, irritability and difficulty breathing.

    The advisory panel’s proposal has fierce opposition from other medical experts in the field of maternal health, with some arguing that the proposed warning labels are misinformed and disregard the serious risks of untreated depression in mothers.

    “[The] FDA panel on SSRIs and pregnancy was alarmingly unbalanced and did not adequately acknowledge the harms of untreated perinatal mood disorders in pregnancy,” said Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists. “On a panel of 10 experts, only one spoke to the importance of SSRIs in pregnancy as a critical tool, among others, in preventing the potentially devastating effects of anxiety and depression when left untreated during pregnancy.”

    Mental health conditions are the most frequent cause of pregnancy-related death, according to the Centers for Disease Control and Prevention.

    “Unfortunately, the many outlandish and unfounded claims made by the panelists regarding SSRIs will only serve to incite fear and cause patients to come to false conclusions that could prevent them from getting the treatment they need,” Fleischman said.

    The Massachusetts General Hospital Center for Women’s Mental Health had a similar reaction to the panel’s suggestion of a warning label.

    “Only one of the ten panelists was a clinician — an obstetrician and psychiatrist — who treats women with psychiatric disorders during pregnancy,” the center said on its website. “However, more concerning than the voice of a single individual who shares an opinion about a subject that affects so many, is when an organization such as the FDA represents such an unbalanced view to the public as evidence; that is when patients are put at risk.”

    This story was reported on-air by a journalist and has been converted to this platform with the assistance of AI. Our editorial team verifies all reporting on all platforms for fairness and accuracy.

    Reply

21. Dr. David Healy says

    July 31, 2025 at 12:23 pm

    The F.D.A.’s Panel on Antidepressants During Pregnancy Was Alarmingly Biased
    By Jessica Grose Opinion Writer July 30, 2025

    https://www.nytimes.com/2025/07/30/opinion/fda-pregnancy-antidepressants-prozac.html?unlocked_article_code=1.ak8.xb8j.TN6Sa5lGEcGu&smid=url-share

    In 2011 I stopped taking Prozac because I wanted to conceive, and I wanted my baby to be as healthy as possible. I had experienced two bouts of major depressive disorder at that point, but my symptoms were well controlled by medication. Still, I tapered off the antidepressant, which is in a class of drugs called selective serotonin reuptake inhibitors, under a psychiatrist’s care. I was med-free by January 2012.

    My doctor at the time never informed me of the risks of going off antidepressants for someone with my clinical history. Even back then, there was research showing that pregnant women with a history of clinical depression had a high rate of relapse if they went off their meds. Use of S.S.R.I.s by pregnant women has been widely studied; while there are certainly risks associated with the medications (they include a slight increase in absolute risk of postpartum hemorrhage and pre-eclampsia for the mother and a moderately increased risk of preterm birth and low birth weight), there is ample evidence that untreated depression in mothers can have its own set of risks, including low birth weight and preterm birth.

    I was pregnant by March, and by April my depression had relapsed. My extreme morning sickness didn’t help matters, but I was a wreck. I wasn’t sleeping, and I was so anxious that I bordered on delusional. I was convinced there would be a sarin gas attack on the subway, and every commute felt like a panic attack. My voice slowed and quieted, which is a typical cognitive sign of depression. I went back on Prozac by the end of my first trimester, and while my morning sickness was still oppressive, my mental health improved radically.
    I wasn’t an outlier in terms of going off meds. Studies have shown that almost half of women who are on antidepressants stop taking them while pregnant, and according to a study of nearly 400,000 women published in January, these women “did not appear to substitute with psychotherapy” — in fact, there was “a slight decrease in psychotherapy claims relative to a trend line.”

    I tell you this as background for why I was eagerly awaiting the Food and Drug Administration’s “expert” panel last week on S.S.R.I.s and pregnancy. I was hoping for an in-depth, nuanced discussion of the benefits versus the risks of these well-studied drugs. I wanted someone to talk about how mental health care is inaccessible for so many pregnant women, and why those who would benefit from talk therapy alone may not be able to get it. I wanted to hear them discuss how ashamed many pregnant women feel if they are struggling with their mental health, because there is so much pressure to be joyful and glowing.

    But that’s not what happened. Most of the panelists were clearly biased against antidepressant use, and some disclosed conflicts of interest in a research paper that went undisclosed during the presentation. Some went as far as arguing that depressed pregnant women weren’t experiencing medical problems at all, even though the Centers for Disease Control and Prevention found that in 2020, mental health conditions were the leading cause of pregnancy-related deaths in the United States.

    One panelist, Roger McFillin, a clinical psychologist, wondered aloud if women are “just naturally experiencing their emotions more intensely.” He characterized those emotions as “gifts,” adding, “They’re not symptoms of a disease.”

    After the panel he published a truly bizarre newsletter, a failed attempt at humor purporting to be a PowerPoint from Satan, in which the devil himself says: “This isn’t about medicine. This is about souls. Every woman we convince to depend on our chemicals instead of trusting her divine inner guidance is a soul we’ve successfully separated from her creator.” OK, then!

    Lizzy Lawrence, who covers the F.D.A. for the health and medicine website STAT, reported: Nine out of 10 panelists have either been paid witnesses in litigation involving antidepressants, run media platforms rooted in S.S.R.I. skepticism or have published research pointing to the drugs’ potential risks in developing babies. Many share the views of health secretary Robert F. Kennedy Jr., who has called S.S.R.I.s harder to quit than heroin and has falsely linked them to mass shootings.

    This is not how F.D.A. expert panels have generally been conducted under previous administrations. Dr. Reshma Ramachandran, a primary care physician and the co-director of the Yale Collaboration for Regulatory Rigor, Integrity and Transparency, said the way this panel was set up and presented is “highly, highly unusual.”

    She told me that the F.D.A. typically has its own scientists describe the current state of evidence on a topic and frame these discussions around specific questions the agency wants answered, which did not happen here. In terms of the panelists themselves, Dr. Ramachandran said that conflicts of interest “would have been publicly made known and also probably vetted out, to be frank.”

    I asked the F.D.A. about the widespread perception that the panel was biased against S.S.R.I.s. For example, the American College of Obstetricians and Gynecologists said the panel was “alarmingly unbalanced and did not adequately acknowledge the harms of untreated perinatal mood disorders in pregnancy.” An F.D.A. spokesperson responded, “The claim that the F.D.A.’s expert advisory process is ‘one-sided’ or politically driven is insulting to the independent scientists, clinicians and researchers who dedicate their expertise to these panels.”

    I talked to the one panelist who expressed the consensus view of the A.C.O.G. and other professional medical organizations, Dr. Kay Roussos-Ross. She’s an obstetrician and the director of the perinatal mood disorders program at the University of Florida. She said that an oft-repeated claim among the other panelists — that women and their doctors are underplaying the risks of S.S.R.I. use — isn’t accurate. It’s more likely that women are cautioned not to take drugs of any kind during pregnancy.

    The risks of medications are discussed and sometimes overstated, while the risks of the untreated disease aren’t talked about enough. “We need to increase education of all clinicians, OB-GYNs, family medicine, internal medicine, nurse practitioners, midwives, everybody on the safety profile of medications,” Dr. Roussos-Ross told me.

    It’s not clear whether this panel discussion will eventually lead to a limiting of access to antidepressant medication for pregnant women. If the F.D.A. tried to put a warning label on or narrow approval for these medications without solid evidence for doing so, there would likely be a lot of public pushback and litigation, Dr. Ramachandran said. But she worries that even having a panel filled with biased contributors could have a “chilling effect” on pregnant women struggling with mental health, because for many it could color their perceptions of drugs that have a good risk profile when prescribed appropriately.

    I worry about how this plays out in a post-Roe America. Some obstetricians are already finding it difficult to treat high-risk pregnancies in states with restrictive abortion laws. I don’t think it’s a stretch to imagine that, at some point, these embattled physicians may be discouraged from prescribing antidepressants to their patients if the F.D.A. exaggerates their downsides.

    None of this means that there aren’t open questions on antidepressants, about their use by pregnant women and others. I personally would love to see more research on long-term use of S.S.R.I.s, because there is so much we don’t know. But it shouldn’t be too much to ask that the federal government hold good-faith scientific discussions with unbiased experts.

    I can’t go back in time, but I wish I’d been given better information about the benefits and risks of antidepressants during pregnancy, so that I could have made a decision about going off them based on something other than a vague fear of anything that was “unnatural.” But I hope that sharing my story is instructive.

    I got through my first pregnancy on Prozac, and my older daughter was born four days after her due date at a robust nine pounds. I stayed on the medication through the birth of my younger daughter, who was a week late and eight pounds, six ounces. I haven’t had another bout of serious depression since my first pregnancy. My children are thriving. The choices I made aren’t the right choices for everyone. For a patient without a history of depression or more moderate symptoms, talk therapy may be a better way to go.

    But after that first bad outcome, the decisions I made were in collaboration with experts in maternal mental health who went over my options with care and deep knowledge. And that’s what matters here. I promise that Satan was not involved.

    Reply

22. Dr. David Healy says

    August 1, 2025 at 12:03 am

    How FDA panelists casting doubt on antidepressant use during pregnancy could lead to devastating outcomes for mothers
    https://theconversation.com/how-fda-panelists-casting-doubt-on-antidepressant-use-during-pregnancy-could-lead-to-devastating-outcomes-for-mothers-261825
    The Conversation July 31st Nicole Pensak and Andrew Novick

    At a meeting held by the Food and Drug Administration on July 21, 2025, a panel convened by the agency cast doubt on the safety of antidepressant medications called selective serotonin reuptake inhibitors, or SSRIs, in pregnancy.

    Panel members discussed adding a so-called black box warning to the drugs – which the agency uses to indicate severe or life-threatening side effects – about the risk they pose to developing fetuses. Some of the panelists who attended had a history of expressing deep skepticism on antidepressants.

    SSRIs include drugs like Prozac and Zoloft and are the most commonly used medicines for treating clinical depression. They are considered the first-line medications for treating depression in pregnancy, with approximately 5% to 6% of North American women taking an SSRI during pregnancy.

    We are a psychologist certified in perinatal mental health and a reproductive psychiatrist and neuroscientist who studies female hormones and drug treatments for depression. We are concerned that many claims made at the meeting about the dangers of those drugs contradict decades of research evidence showing that antidepressant use during pregnancy is low risk when compared with the dangers of mental illness.

    As clinicians, we have front-row seats to the maternal mental health crisis in the U.S. Mental illness, including suicide and overdose, is the leading cause of maternal deaths. Like all drugs, SSRIs carry both risks and benefits. But research shows that the benefits to pregnant patients outweigh the risks of the SSRIs, as well as the risks of untreated depression.

    The panel did not address the safety of SSRIs following delivery, but numerous studies show that taking SSRI antidepressants while breastfeeding is low risk, usually producing low to undetectable drug levels in infants.
    The biology of maternal brain health

    Pregnancy and the months following childbirth are characterized by so many emotional, psychological and physical changes that the transition to motherhood has a specific name: matrescence. During matrescence, the brain changes rapidly as it prepares to efficiently take care of a baby.

    The capacity for change within the brain is known as “plasticity.” Enhanced plasticity during pregnancy and the postpartum period is what allows the maternal brain to become better at attuning to and carrying out the tasks of motherhood. For example, research indicates that during this period, the brain is primed to respond to baby-related stimuli and improve a mother’s ability to regulate her emotions. These brain shifts also act as a mental buffer against aging and stress in the long term.

    On the flip side, these rapid brain changes, fueled by hormonal shifts, can make people especially vulnerable to the risk of mental illness during and after pregnancy. For women who have a prior history of depression, the risk is even greater.

    Clinical depression interferes with brain plasticity, such that the brain becomes “stuck” in patterns of negative thoughts, emotions and behaviors.

    This leads to impairment in brain functions that are essential to motherhood. New mothers with depression have decreased brain activity in regions responsible for motivation, regulation of emotion and problem-solving. They are often withdrawn or overprotective of their infants, and they struggle with the relentless effort needed for tasks that arise with child-rearing like soothing, feeding, stimulating, planning and anticipating the child’s needs.

    Research shows that SSRIs work by promoting brain plasticity. This in turn allows individuals to perceive the world more positively, increases the experience of gratification as a mother and facilitates cognitive flexibility for problem-solving.

    Assessing the risks of SSRIs in pregnancy
    Prescription drugs like SSRIs are just one aspect of treating pregnant women struggling with mental illness. Evidence-based psychotherapy, such as cognitive behavioral therapy, can also induce adaptive brain changes. But women with severe symptoms often require medication before they can reap the benefits of psychotherapy, and finding properly trained, accessible and affordable psychotherapists can be challenging. So sometimes, SSRIs may be the most appropriate treatment option available.

    Multiple studies have examined the effects of SSRIs on the developing fetus. Some data does show a link between these drugs and preterm birth, as well as low birth weight. However, depression during pregnancy is also linked to these effects, making it difficult to disentangle what’s due to the drug and what’s due to the illness.
    SSRIs are linked to a condition called neonatal adaption syndrome, in which infants are born jittery, irritable and with abnormal muscle tone. About one-third of infants born to mothers taking SSRIs experience it. However, research shows that it usually resolves within two weeks and does not have long-term health implications.
    The FDA-convened panel heavily focused on potential risks of SSRI usage, with several individuals incorrectly asserting that these drugs cause autism in exposed youth, as well as birth defects. At least one panelist discussed clinical depression as a “normal” part of the “emotional” experience during pregnancy and following birth. This perpetuates a long history of of women being dismissed, ignored and not believed in medical care. It also discounts the rigorous assessment and criteria that medical professionals use to diagnose reproductive mental health disorders.

    A summary of the pivotal studies on SSRIs in pregnancy by the Massachusetts General Hospital Center for Women’s Health discusses how research has shown SSRIs to not be associated with miscarriage, birth defects or developmental conditions in children, including autism spectrum disorder.

    The risks of untreated mental illness
    Untreated clinical depression in pregnancy has several known risks. As noted above, babies born to mothers with clinical depression have a higher risk of preterm birth and low birth weight.

    They are also more likely to require neonatal intensive care and are at greater risk of behavioral problems and impaired cognition in childhood.

    Women who are clinically depressed have an increased risk of developing preeclampsia – a condition involving high blood pressure that, if not identified and treated quickly, can be fatal to both mother and fetus. Just as concerning is the heightened risk of suicide in depression. Suicide accounts for about 8% of deaths in pregnancy and shortly after birth.

    Compared with these very serious risks, the risks of using SSRIs in pregnancy turn out to be minimal. While women used to be encouraged to stop taking SSRIs during pregnancy to avoid some of these risks, this is no longer recommended, as it exposes women to a high chance of depression relapse. The American College of Obstetricians and Gynecologists recommends that all perinatal mental health treatments, including SSRIs, continue to be available.

    Many women are already reluctant to take antidepressants during pregnancy, and given the choice, they tend to avoid it. From a psychological standpoint, exposing their fetus to the side effects of antidepressant medications is one of many common reasons for women in the U.S. to feel maternal guilt or shame. However, the available data suggests such guilt is not warranted.

    Taken together, the best thing one can do for pregnant women and their babies is not to avoid prescribing these drugs when needed, but to take every measure possible to promote health: optimal prenatal care, and the combination of medications with psychotherapy, as well as other evidence-based treatments such as bright light therapy, exercise and adequate nutrition.

    The panel failed to address the latest neuroscience behind depression, how antidepressants work in the brain and the biological rationale for why doctors use them in the first place. Patients deserve education on what’s happening in their brain, and how a drug like an SSRI might work to help.

    Depression during pregnancy and in the months following birth is a serious barrier to brain health for mothers. SSRIs are one way of promoting healthy brain changes so that mothers can thrive both short- and long-term.
    Should the FDA, as a result of this recent panel, decide to place a black-box warning on antidepressants in pregnancy, researchers like us already know from history what will happen. In 2004, the FDA placed a warning on antidepressants describing potential suicidal ideation and behavior in young people.

    In the following years, antidepressant-prescribing decreased, while the consequences of mental illness increased. And it’s easy to imagine a similar pattern in pregnant women.

    Reply

23. Dr. David Healy says

    August 1, 2025 at 3:48 pm

    NPR again – they’ve recently had their budget slashed by the government

    An FDA panel spread misinformation about SSRI use in pregnancy, alarming doctors
    https://www.npr.org/sections/shots-health-news/2025/08/01/nx-s1-5487710/fda-panel-ssri-antidepressants-pregnancy-perinatal
    August 1, 20256:00 AM ET Rhitu Chatterjee

    Nearly one in five pregnant women and new moms in this country suffers from anxiety and depression. And 6-8% of pregnant women are prescribed a group of antidepressants called Selective Serotonin Reuptake Inhibitors (SSRIs).

    But a recent expert panel organized by the U.S. Food and Drug Administration cast doubt on the safety of SSRIs — even though these drugs are largely considered safe by healthcare providers.

    Those comments have sparked a swath of criticism from a number of prominent medical societies.
    “Untreated or undertreated depression during pregnancy carries health risks, such as suicide, preterm birth, preeclampsia, and low birth weight,” the Society for Maternal-Fetal Medicine wrote in a statement late last month. “Unfortunately, misinformation about depression and its treatment creates confusion and doubt among patients and the public leading to unnecessary barriers to care.”

    Opening the panel discussion on FDA on July 21, FDA Commissioner Marty Makary said that SSRIs have been “implicated” by studies to be involved in a range of health effects, including pulmonary hypertension and cardiac defects in babies. Then a majority of the panelists, including psychiatrists, psychologists and a social work professor, cited studies they said illustrate serious health risks, like miscarriage and autism.
    Several groups of healthcare providers, including the American College of Obstetricians and Gynecologists (ACOG) and the National Curriculum for Reproductive Psychiatry have spoken out against many of the claims made by the panel, saying that it misrepresented evidence and spread misinformation.

    Pregnancy is a brain changer that prepares a mouse for parenting
    “As experts in high-risk pregnancies, the Society for Maternal-Fetal Medicine (SMFM) and its members are alarmed by the unsubstantiated and inaccurate claims made by FDA panelists concerning maternal depression and the use of SSRI antidepressants during pregnancy,” according to the statement from SMFM.

    “Robust evidence” illustrates the safety of SSRI use in pregnancy, according to the ACOG statement, which added that most of these medications “do not increase the risk of birth defects.”

    Responding to that criticism, spokesperson for the Department of Health and Human Services, Andrew Nixon wrote this to NPR in an email: “The claim that the FDA’s expert advisory process is one-sided or politically driven is insulting to the independent scientists, clinicians, and researchers.”

    Scientific ‘apples and oranges’
    Some of the studies cited by the panelists as evidence of harm didn’t even involve pregnant and postpartum women, says Dr. Jennifer Payne, a reproductive psychiatrist at the University of Virginia and a past president of the Marcé of North America, an organization working to prevent and treat mental health conditions during and after pregnancy.

    For example, British psychiatrist Dr. Joanna Moncrieff referenced a study in youth linking SSRIs to increased suicidality in a “very small proportion of” those taking the medication, she said.

    Many of the studies referenced by some panelists have been disproven, notes Payne, like the papers linking SSRI use in pregnancy to cardiac defects in infants. “That has been debunked over and over,” she says.
    And several studies mentioned on the panel were “poorly controlled,” says Payne.

    “So if you’re comparing a pregnant patient who was taking an SSRI, the control group should be the pregnant patient with mental health abnormalities who hasn’t taken an SSRI,” explains Dr. Christopher Zahn, chief of Clinical practice with the American College of Obstetricians and Gynecologists or ACOG, who wasn’t part of the panel. “And part of the problem with a number of those studies [cited by panelists] is they don’t use the right control group. It’s really apples and oranges.”

    And studies that are well-controlled — in other words, those that compare pregnant women on SSRIs with pregnant women with mental health conditions not taking the drugs — do not find the risks highlighted by the FDA panel.
    “The use of SSRIs in pregnancy is extremely well studied,” says Dr. Nancy Byatt, a perinatal psychiatrist at the UMass Chan School of Medicine. “We have data on hundreds and thousands of individuals exposed to SSRIs in pregnancy.”

    That data show that by and large, SSRI’s are safe. “What the overall data shows is that antidepressants are not associated with major birth defects,” says Byatt. And neither are they associated with a significantly higher risk of miscarriage or postpartum hemorrhage, as suggested by some panelists.

    The impacts of untreated perinatal depression
    One issue that was not discussed enough by the panel, according to Byatt and other experts on perinatal mental health, is the well-documented health impacts of untreated mental health symptoms in pregnant and postpartum women. Only one panelist, Dr. Kay Roussos-Ross, OBGYN and perinatal psychiatrist at the University of Florida, spelled out those impacts.

    “When mental health conditions go untreated, these women are less likely to attend their prenatal care appointments and they’re more likely to use substances during their pregnancy,” said Roussos-Ross. “They are also more likely to face additional risks, such as pre-eclampsia and cesarean delivery.” They’re also at a higher risk of suicide, she said. Mental health remains the leading cause of maternal deaths in the United States, including deaths from suicide.

    “And there’s this huge literature on the effects of postpartum depression, on IQ, language development, behavioral problems” in children, says Payne. “It’s as clear as a bell that you want mom to be well, during pregnancy and postpartum.”

    However, SSRIs aren’t the only treatment option for pregnant and postpartum women, say Payne and others.
    “We have a lot of tools in our toolbox,” says Byatt.

    For mild depression or anxiety, the first line of treatment is psychotherapy, or talk therapy, she says. “We have evidence-based psychotherapies that we can, should and do use in pregnancy and postpartum.”
    There’s also psychosocial treatments, like peer support, which can be very helpful in improving pregnant women’s and new moms’ symptoms.

    Adding practices like exercise, yoga and meditation to those treatments is also something Byatt recommends to her patients.

    “Often people can’t access therapy quickly because of lack of insurance or even if people do have insurance, it’s extraordinarily challenging for people to access evidence-based quality therapy,” notes Byatt.
    So for those women, and ones with moderate to severe symptoms, she says, SSRIs are a helpful option.

    Reply

24. Dr. David Healy says

    August 2, 2025 at 3:57 am

    The Royal College of Psychiatrists has semi-stepped into the frame also?

    https://www.rcpsych.ac.uk/news-and-features/latest-news/detail/2025/07/24/postnatal-depression-harming-up-to-85-000-new-mums-in-england–warns-rcpsych

    Postnatal depression harming up to 85,000 new mums in England, warns RCPsych
    24 July 2025

    New and expectant mothers are at risk of postnatal depression and other mental illnesses from conception to a year after birth, which could be prevented or treated with the right support.

    The Royal College of Psychiatrists (RCPsych) is raising awareness of the benefits of perinatal mental health care, including talking therapies and antidepressants which are proven to help people recover from anxiety, depression and other mental illnesses.

    RCPsych estimates that between 56,000 and 85,000 mothers (10-15% of those who gave birth) across England may have experienced postnatal depression last year (2024).1,2

    Maternal suicide remains one of the leading causes of death among women between six weeks and a year after birth. Perinatal mental illness can significantly impact women’s health and accounts for 34% of all deaths in this group during this period.3

    Untreated prenatal mental illness also affects unborn infants, potentially putting them at risk of premature birth and low birth weight. Parents may find it difficult to bond with their baby once they are born and this can contribute to attachment issues.

    Mothers and their partners must not be left to suffer in silence and should instead be supported to seek help from those around them as well as perinatal mental health services when necessary. These conditions are eminently treatable, and an approach that takes into account a person’s biological needs, psychological state and social situation is most effective.

    Dr Trudi Seneviratne OBE, Consultant Perinatal Psychiatrist and immediate past RCPsych Registrar, said:
    “Women can experience an enormous amount of change, including increased stress factors when they become pregnant, and this may negatively affect their mental health. Postnatal depression is far more common than many people realise and can have a devastating impact on mothers, babies and families if left untreated.

    “Mothers who receive talking therapy and other forms of care from mental health services will often be able to recover, but some might be so unwell that they need medication, including antidepressants. Medication helps save lives. The dangers of untreated depression far outweigh the risks of antidepressants. The unnecessary deaths of mothers and sometimes their babies that result from failure to treat these conditions are truly devastating.

    “Doctors are trained to ensure that the medication they prescribe is as safe as possible to take while pregnant or breastfeeding. Medication should be reviewed regularly, and any side effects closely monitored.

    “For children to thrive, they need as good a start in life as possible, and this is important not only for the child and their mother but also communities and society as well. We all have a role to play in ensuring mothers and their partners feel confident seeking support when they need it.”

    We would advise all those thinking of stopping their antidepressants to talk to their doctor first, as these medications should not be stopped abruptly. The RCPsych has produced a resource for anyone who wants more information about stopping antidepressants.

    Footnotes
    1. Postnatal depression is estimated to affect between 10% and 15% of mothers – A systematic review and meta-regression of the prevalence and incidence of perinatal depression – PubMed
    2. The Office for National Statistics states that 567,708 live births were recorded in England in 2024 – Births in England and Wales – Office for National Statistics. The Royal College of Psychiatrists therefore estimates that up to 85,000 mothers could have been affected by postnatal depression in 2024.
    3. Saving Lives, Improving Mothers’ Care 2024 – Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2020-22 | MBRRACE-UK | NPEU
    4. RCPsych has produced a resource which provides mothers who are pregnant or breastfeeding with information about antidepressants – Antidepressants.

    Reply

25. Dr. David Healy says

    August 3, 2025 at 4:06 pm

    NYT Grose on Grose

    Jessica Grose wrote a Thumbnail of her Opinion for NYT’s August 2nd Newsletter

    When I heard that the Food and Drug Administration was holding an expert panel on antidepressant use during pregnancy, I was not especially optimistic that it would present a balanced picture of the risks and benefits of S.S.R.I. use for struggling mothers and their babies.

    That’s because Robert F. Kennedy Jr., the secretary of health and human services, does not seem to be a fan of the medications. Kennedy has repeated claims about S.S.R.I.s, like linking their use to school shootings, that are not evidence based. (He is all in on psychedelics as a treatment for mental illness, which doesn’t really track with his other beliefs on the root causes of chronic diseases, but I have given up on trying to make him make sense.)

    So I wasn’t really surprised when I tuned in to the July 21 panel and found it stacked with “experts” who emphasized the risks of taking the medications and barely discussed the risks of untreated depression in pregnant women. There was no mention of the fact that in 2020, mental health conditions were the leading underlying cause of death during pregnancy in the United States. Only one panelist out of 10 was aligned with the consensus view of the medical associations that treat pregnant women in the United States.

    Some of the panelists had conflicts of interest — like participation in litigation involving antidepressants — that went undisclosed during the discussion. Others, like Roger McFillin, a clinical psychologist, went so far as to imply that prenatal depression is not a medical issue. It’s simply that women are “just naturally experiencing their emotions more intensely.” In other words: It’s all in our heads.

    I say “our” because I am someone who experienced prenatal depression. I went off Prozac before conceiving my older daughter over a decade ago, and I was not informed about the risks of untreated depression and anxiety in pregnancy for both me and my baby, nor about the rate of relapse for someone with my medical history. I might have still chosen to go off the medication, but I would have been doing so with all the facts at hand and with a better plan in place for all of the potential outcomes.

    I am no fan of big pharma. I agree with Kennedy about prescription drug advertising, for example, and have argued that it should be banned. But we’re not going to get the “gold standard” science that Kennedy keeps promising if F.D.A. panels continue to include such biased, conflicted and unqualified participants.

    Reply

26. Dr. David Healy says

    August 5, 2025 at 5:54 pm

    The Guardian commented as follows – written by an American

    I’m a perinatal psychiatrist. The US is promoting misinformation on SSRIs and pregnancy
    Sunny Patel Guardian Tue 5 Aug 2025
    https://www.theguardian.com/commentisfree/2025/aug/05/perinatal-psychiatrist-ssri-pregnancy-misinformation

    A recent FDA advisory panel discussion contained falsehoods and overstated risks.

    Late last month, the FDA advisory panel – on the heels of the president’s “make America healthy again” executive order scrutinizing psychotropic medications – raised debate around the safety of selective serotonin reuptake inhibitors (SSRIs) in pregnancy. Commonly called antidepressants, these medications are used to treat a range of disorders, and earlier this year a consortium of major mental health organizations pushed back on the administration’s stance.

    As a perinatal psychiatrist who sees pregnant and postpartum people struggling with conditions such as depression and anxiety every week, I’m deeply concerned that this public discussion – chaired by the controversial FDA commissioner Marty Makary – shared significant misinformation about mental illness and the treatment modalities (with overly simplified statements denouncing “chemicals” during pregnancy).

    Here in Washington DC, I recently examined a pregnant woman struggling with severe depression and anxiety. As she was nervously mulling treatment options we had discussed, she asked me questions about starting medication to treat her condition: will this affect my child’s development? How long will the medication stay in my child’s bloodstream? How much of the medication will go into my breast milk? Do I have to stay on it for ever?

    These questions are part of everyday practice for those who care for individuals making decisions about treating their mental health challenges in the course of pregnancy. And answering them clearly is critical for people already dealing with some of the most difficult and vulnerable moments of their lives.

    But giving established guidance becomes difficult at a time when the authorities themselves are platforming misinformation under the guise of scientific inquiry.

    There isn’t enough space here to deconstruct all of the falsehoods shared by some of the FDA panelists, with often meandering anecdotes that did not address the core issue being discussed.

    The panelists overstated risks, which may deter treatment, despite robust data supporting the safety of use of SSRIs when clinically indicated.

    As the adage attributed to W Edwards Deming goes: “In God we trust; all others, bring data.” Here’s the data: we know that severe maternal mental health challenges occur during pregnancy and the postpartum period. And according to a recent national study, there have been large declines in mental health among pregnant women – one in five pregnant women struggles with conditions such as anxiety and depression during their pregnancy. Three in four pregnant persons are untreated. That’s more than 500,000 people every year who experience significant mental health issues before, during or after their pregnancies.

    There are also real harms of untreated perinatal depression and anxiety – such as preterm birth, bonding difficulties, and even maternal death by suicide or overdose. The low, manageable neonatal risks generally support initiating and continuing SSRIs when they’re clinically needed. These women need and deserve evidence-based care.

    And as for pregnant people who do take SSRIs, large reviews, called meta-analyses, find no overall rise in major birth defects from taking SSRIs during pregnancy, and occasional small links to heart problems with certain drugs disappear in larger studies. Some newborns exposed late in pregnancy may have an issue called neonatal adaptation syndrome – mild, brief withdrawal-like symptoms which include jitteriness, poor feeding and affect the baby’s breathing – but this almost always clears up quickly with routine care in the first week.

    There is also an inherent problem in the way the FDA panelists spoke about the issue: one that minimized the health of the mother and focused solely on the baby. I am the first person to say there is a dearth of science when it comes to maternal mental healthcare. We need more research, and it is unfair that so many are left scrambling for help outside of our health system. But we should be seriously weighing the risk of not treating these conditions because mental illness is real and has significant impacts on the wellbeing of the pregnant person and baby.

    SSRIs are not new drugs – they’ve been on the market for more than 30 years, and if there is a widespread epidemic of the harms that the FDA panel claimed, it is not substantiated in the data. So let’s not apply an inconsistent standard towards SSRIs in pregnancy. Their comments that we need more data is the last slide or nearly every scientific discussion – of course, we need more robust data. That shouldn’t seed unnecessary doubt and leave patients and their doctors in a limbo on how best to treat these conditions.

    We need the right treatment, for the right patient, at the right time. In this moment when trust in government institutions is at a low, sowing further doubt is the last thing my patients deserve. The American public needs to know they are getting the highest quality guidance; in the absence of that, lives are at risk.

    As we’ve seen in the case of vaccines, official federal guidance has been rapidly changing and is often out of alignment with the best science available. Professional medical societies are currently filling the void where government guidance falls short. If this panel on SSRIs is a harbinger of what’s to come, this might become the case for SSRIs in pregnancy. The American Psychiatric Association and American College of Obstetrics and Gynecology have expert guidance on treatment, including psychotropic medications.

    As for my patient, we evaluated the data – doctor and patient – and together she made an informed decision weighing the risks and benefits to start an SSRI along with therapy. Her mood and anxiety improved, and she had a safe delivery. Both mother and baby are thriving.

    Dr Sunny Patel is a psychiatrist at Georgetown’s Thrive Center for Children, Families, and Communities. He recently served as senior adviser at SAMHSA

    Reply