Following the FDA Panel on SSRIs and pregnancy, there have so far been 25 English language US-based media reports and counting. These are reproduced following the UnSafe Safety Systems post. There will likely be more from professional medical groups and medical journals which will be posted after this post. Anything anyone spots would be good to get.
All comments on these reports should be posted linked to FDA Panel on SSRIs and Pregnancy or There’s Something About Pregnant Mary
My name is Adam Urato. I’m a maternal-fetal medicine physician in my hometown of Framingham, Massachusetts. I have no disclosures. First off, thank you to Commissioner Makary, Dr. Hoeg, the FDA and to all of you.
I’ve been taking care of pregnant women in my hometown for the past 20 years. I take care of my patients as if they were my neighbors, because they are my neighbors. So I really believe in compassionate care, particularly for pregnant women with depression. A big part of compassionate care is giving patients the proper information about risks and benefits of treatment, and then supporting their choices.
Over the years I’ve seen more and more medication use in pregnancy, and I think that pregnant women and the public aren’t being properly informed on this issue, particularly with SSRI antidepressants. Patients regularly tell me that essentially the only counseling they received is that SSRI’s don’t affect the baby or cause complications. This is simply not accurate or adequate. But this is essentially what you could conclude based on the current FDA labels for these drugs.
The public needs better information, and the FDA must strengthen the warnings. For example, there’s currently no warning regarding preterm birth or pre-eclampsia. The postpartum hemorrhage warning needs to be strengthened. But perhaps the major shortcoming is that the label doesn’t make clear that SSRI’s alter fetal brain development. The public needs to know this. There is general scientific agreement that SSRI’s impact the developing fetal brain. The research shows this. When a pregnant mom takes an SSRI chemical, that chemical enters the mom, crosses the placenta, goes into the developing fetal brain, and has chemical effects. That’s what chemicals do. Chemicals have consequences.
There is widespread scientific agreement on the following three points. Number one, serotonin plays a crucial role in fetal development. No scientists disagree with this. Number two, the SSRI’s disrupt the serotonin system. This is how they are understood to work. And number three, SSRI’s freely cross the placenta.
So just think about it. If serotonin plays a crucial role in fetal development – and it does – and if the SSRI’s cross the placenta and disrupt the serotonin system – which they do – then the SSRI’s must disrupt fetal development.
But it’s not just common sense. Research supports this. Basic science research shows that SSRI’s impact individual neurons and the developing brain. Many animal studies show that SSRI’s alter the development of rats, mice, rabbits and sheep. When those mammals grow up, they behave differently. Socially their behaviors are described as autistic-like, and they also have altered sexual behaviors.
And then there are the human studies. Numerous human studies show links to birth defects, miscarriage, preterm birth, low birth weight, pre-eclampsia and postpartum hemorrhage. And many, many studies show impact on the developing brain. These drugs alter the mom’s brain. Why wouldn’t they affect the baby’s?
We can see it on prenatal ultrasound. The ultrasound studies show SSRI-exposed fetuses have different movement and behavior patterns. After birth the newborn babies can have jitteriness, breathing difficulties, and higher rates of admission to the neonatal intensive care unit.
By my count there are now a dozen consecutive MRI studies showing that prenatal SSRI exposure alters the developing brain. That’s right: twelve studies. I mean, what are we waiting for before we warn the public – fifteen studies? Twenty?
Longer-term studies show higher rates of speech and language difficulty, autism and depression.
My patients often ask me, “Don’t these SSRI’s affect the developing baby?” The answer, based on simple common sense and scientific research, is clearly yes. Yet this information is not getting out to women of childbearing age and the public, and this is a problem. The SSRI’s can be very difficult to get off of. So the time to think about these things is long before pregnancy.
I also want to note that accurately informing patients doesn’t mean you’re trying to pill-shame them or guilt-trip them. Many of my patients choose to stay on their SSRI’s, and I continue to support them and give them good care. The key is information.
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. That must end. There is now more than enough evidence to support stronger warnings from the FDA about how these drugs disrupt fetal development and impact the moms. Thank you again, and I look forward to our discussion.
Added 2 weeks later from Adam in response STAT/WBUR:
“Not traditional”
“Not surprising the FDA panel would have this bias”
This @wbur segment is titled “What is the risk of taking antidepressants during pregnancy?”
https://wbur.org/hereandnow/2025/08/01/pregnancy-antidepressants
In 6 min. @LizzyLaw_@tongscott don’t clearly note ANY risks – & even walk back Paxil concerns.
This is an example of what I mean when I say that the public is not being accurately informed re: risks of SSRIs in pregnancy.
Those risks are miscarriage, birth defects, preterm birth, low birthweight, preeclampsia, postpartum hemorrhage, & poor neonatal adaptation. The SSRIs also alter fetal brain development, with evidence showing long-term effects on the children including speech/language difficulties, depression, & other neurobehavioral issues.
Johanna Ryan who Transcribed the interview comments:
The US medical establishment and their Pharma sponsors have denounced this FDA panel on Antidepressants in Pregnancy as simply part of the Trump Administration war on women. Or, as the New York Times summed it up: The FDA is telling pregnant women in mental distress that “it’s all in your head.”
This may be convincing to some well-meaning people who are furious with other Trump-linked policies, like extreme anti-abortion laws in many states and drastic cuts to programs that subsidize healthy food for moms and young children. So I think this quote from Dr. Urato is well worth sharing:
“… accurately informing patients doesn’t mean you’re trying to pill-shame them or guilt-trip them. Many of my patients choose to stay on their SSRI’s, and I continue to support them and give them good care.
The key is information.”
Amen
Dr. David Healy says
The American Psychiatric Association weighed in as follows:
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 perinatal specific 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
Watch this space for a response in due course. I am waiting for APA’s response to my letter
Dr. David Healy says
Watch this space for a response in due course. I am waiting for APA’s response to my letter
DH
Dr. David Healy says
The Royal College of Psychiatrists in Brain said the following:
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.
Dr. David Healy says
Medpage wrote:
A ‘Black Box’ Warning for SSRIs in Pregnancy Would Do More Harm Than Good — An FDA panel discussion failed to accurately reflect medical expertise
David Hackney, MD August 5, 2025
When I was a child, a preschool friend had atypical limbs. Growing up I was told that, when pregnant, his mother had used the medication combination pyridoxine and doxylamine (formerly Bendectin and now sold under the brand name Diclegis) to control her morning sickness, supposedly injuring his arms and legs. As a result, they were suing the manufacturer.
Years later in medical school, I was shocked to learn that pyridoxine/doxylamine in pregnancy is completely safe. Though early reports raised concern for teratogenesis, no risks were later identified in larger, properly controlled studies. The birth defects while using pyridoxine/ doxylamine are now known to have arisen randomly.
Obstetric history is fraught with both true teratogens and untrue teratogenic assertions. The Bendectin litigation in particular haunts our field in modern times, having driven many pharmaceutical companies away from researching obstetric diseases due to the civil risks. Meanwhile patients were left forgoing, for decades, safe treatments for hyperemesis.
On July 21, the (SSRIs) and pregnancy, in which speaker after speaker made assertions of teratogenesis despite study after study showing no clear or meaningful risk of birth defects. Similarly to the pyridoxine/doxylamine controversy, earlier studies had raised concerns about potential negative health effects of SSRI use during pregnancy — particularly for paroxetine (Paxil) and cardiac anomalies. But in subsequent larger and properly controlled cohorts, no risks were identified.
Stated by fewer of the panelists were the profound consequences of untreated depression. This can include suicide, a leading cause of pregnancy-associated death. Thus all major medical organizations — including The American College of Obstetricians and Gynecologists and the Society for Maternal Fetal Medicine (the professional organization of obstetricians who treat patients with high-risk pregnancies) — support SSRIs in pregnancy when indicated and when patients are appropriately counseled.
A Panel Not Reflecting American Medical Expertise
The assembled speakers on the FDA panel were starkly unrepresentative of American medicine. In contrast to prevailing literature, guidelines, and practice, I’d argue that only one of the 10 panelists vocalized a fully mainstream viewpoint. The testimony of Kay Roussos-Ross, MD, offered an imperturbable and rational defense of our patients. She was far outnumbered in the room, yet advanced the position a majority of physicians would likely agree with, stating:
I want to stress that treating mental illness in pregnancy is not a luxury. It’s a necessity. 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. Early identification and interventions positively impact both mothers and their babies. The goal is to achieve the balanced approach where the mother’s mental wellbeing is prioritized and potential risks to the fetus are minimized through shared decision-making and close monitoring.
Most other speakers tripped headlong into the fallacies of teratogenesis: over-interpretation of animal research, equating causation and association, and failing to differentiate possible adverse effects of the drug from adverse effects from the underlying disease. Beyond birth defects, this also applies to medication exposures and obstetric outcomes broadly. For example, if you compare patients taking or not taking antihypertensive medications, pregnancy risks are far worse in the group taking antihypertensives. But the culprit is not the medications, for which exceedingly safe options exist, but rather the patient’s hypertension necessitating them in the first place.
Even for medications with some risks, such as SSRIs and neonatal abstinence syndrome, those risks must be balanced against untreated disease. And even with appropriate controls, one still must rigorously adjust for confounders.
Meanwhile, psychiatrist David Healy, MD, opened his remarks with the jury award from a lawsuit years ago against the maker of Paxil — as if civil trial results are what determines a drug’s true teratogenicity. In the hierarchy of medical evidence, litigation outcomes prove only what plaintiff lawyers can or cannot sell to a jury box. Here with the Paxil narrative we can once again see Bendectin’s tenacious ghost.
Is a Black Box Warning on the Horizon?
The panel discussed whether there should be a black box warning against SSRIs in pregnancy. What would be the impact of formally asserting a risk of anomalies?
Given the baseline incidence of both birth defects and SSRI use, numerous patients will experience both by random chance alone. A black box could be used against physicians in litigation, not just ob/gyns and psychiatrists but all primary care physicians prescribing SSRIs to patients who may later conceive. Additionally, if a warning were added, many pregnant patients who need SSRIs may stop, the pregnancy then endangered by untreated depression risking a decrease in self-care and visit attendance, and initiation of substance use. The danger of suicide in pregnancy cannot be understated.
In response to a black box warning of teratogenicity, doctors would be in the uncomfortable position of disputing FDA’s assertions for patients. This would be injurious to the other, true warnings that we want physicians and the public to heed, as well as to the FDA’s stature itself.
Broader Scrutiny of SSRIs
More fundamentally, how should medicine respond to increasingly ersatz federal institutions? For SSRIs, pregnancy is likely just an opening salvo rather than end goal unto itself. Much of the meeting strayed from obstetrics into broad jeremiads against SSRIs in non-pregnant adults and children.
There may be a future in which physicians of all fields have to tell patients to disregard the FDA. We are already living in a time of enormous distrust in established institutions. What will be the impact of no longer trusting our medical agencies as well?
David Hackney, MD, is a Maternal Fetal Medicine specialist, professor of Reproductive Biology at Case Western Reserve University, and District V Legislative Chair for the American College of Obstetricians and Gynecologists. The views reflected are his own and not those of any organization or employer.
David T Healy says
There is a wonderful post by Adam Urato about these issues on Psychology Today August 12 – Antidepressant Risks in Pregnancy
https://www.psychologytoday.com/us/blog/chemically-imbalanced/202508/antidepressant-risks-in-pregnancy-what-women-need-to-know
D
Dr. David Healy says
JAMA SSRIs and Pregnancy 2004
Health Agencies Update Pregnancy and Medication Tracy Hampton, PhD
JAMA Published Online, 2004;292;1946.doi:10.1001/jama.292.16.1946-b
Substantial numbers of pregnant women are prescribed drugs that the US Food and Drug Administration (FDA) classifies as having no human evidence of safety for use during pregnancy or that evidence has shown can harm a developing fetus, according to a study by investigators at the Agency for Healthcare Research and Quality (Am J Obstet Gynecol. 2004;191:398-407).
The researchers reviewed data focusing on prescription drug use by 152 531 pregnant women from 1996 through 2000. Of these women, 64% were prescribed a medication other than a vitamin or mineral supplement during their pregnancy. Of these, almost 40% received a drug for which human safety during pregnancy has not been established. Nearly 5% were prescribed drugs associated with definite fetal risks in human or animal studies or based on human experience—a risk that outweighs any possible benefit.
The researchers conclude that medication audits, physician education, and computerized prescription systems may have the potential to reduce inappropriate prescribing to pregnant women.
HAMPTON is referring to this article
American Journal of Obstetrics and Gynecology 2004 191, 398-407
Prescription drug use in pregnancy Andrade SE, Gurwitz JH, Davis RL et al
https://doi.org/10.1016/j.ajog.2004.04.025Get rights and content
Abstract
Objective
The purpose of this study was to provide information on the prevalence of the use of prescription drugs among pregnant women in the United States.
Study design
A retrospective study was conducted with the use of the automated databases of 8 health maintenance organizations that are involved in the Health Maintenance Research Network Center for Education and Research on Therapeutics. Women who delivered of an infant in a hospital from January 1, 1996, through December 31, 2000, were identified. Prescription drug use according to therapeutic class and the United States Food and Drug Administration risk classification system was evaluated, with the assumption of a gestational duration of 270 days, with three 90-day trimesters of pregnancy, and with a 90-day period before pregnancy. Nonprescription drug use was not assessed.
Results
During the period 1996 through 2000, 152,531 deliveries were identified that met the criteria for study. For 98,182 deliveries (64%), a drug other than a vitamin or mineral supplement was prescribed in the 270 days before delivery: 3595 women (2.4%) received a drug from category A; 76,292 women (50.0%) received a drug from category B; 57,604 women (37.8%) received a drug from category C; 7333 women (4.8%) received a drug from category D, and 6976 women (4.6%) received a drug from category X of the United States Food and Drug Administration risk classification system. Overall, 5157 women (3.4%) received a category D drug, and 1653 women (1.1%) received a category X drug after the initial prenatal care visit.
Conclusion
Our finding that almost one half of all pregnant women received prescription drugs from categories C, D, or X of the United States Food and Drug Administration risk classification system highlights the importance of the need to understand the effects of these medications on the developing fetus and on the pregnant woman.
References (17)
F. Haramburu et al. Good and bad prescription in pregnancy Lancet (2000)
J.D. Rubin et al. Use of prescription and non-prescription drugs in pregnancy J Clin Epidemiol
(1993)
J.C. Brocklebank et al. Drug prescribing during pregnancy: a controlled study of Tennessee Medicaid recipients Am J Obstet Gynecol (1978)
J.M. Piper et al. Prescription drug use before and during pregnancy in a Medicaid population. Am J Obstet Gynecol (1987)
Buitendijk S et al. Medication in early pregnancy: prevalence of use and relationship to maternal characteristics Am J Obstet Gynecol (1991)
J.M. Piper et al. Maternal use of prescribed drugs associated with recognized fetal adverse drug reactions Am J Obstet Gynecol (1988)
I. Lacroix et al. Prescription of drugs during pregnancy in France Lancet (2000)
P.L. Doering et al. Review of pregnancy labeling of prescription drugs: Is the current system adequate to inform of risks? Am J Obstet Gynecol (2002)
Dr. David Healy says
JAMA Lauren Schneider SSRIs and Pregnancy 2025
JAMA Published Online: August 15, 2025 doi: 10.1001/jama.2025.14105
On July 21, the US Food and Drug Administration (FDA) convened a panel to discuss the use of selective serotonin reuptake inhibitors (SSRIs) to treat depression and other mental health conditions during pregnancy.
Among those invited to speak was Jay Gingrich, MD, PhD, director of the Institute for Developmental Sciences at Columbia University Irving Medical Center, who studies how serotonin affects brain development in mouse models and in cohort studies of children exposed to SSRIs in utero.
Gingrich had prepared a straightforward summary of his research findings and was surprised when his fellow speakers delivered presentations of a different character.
Although his work has identified potential links between in utero SSRI exposure and adolescent depression and anxiety, Gingrich in an interview with JAMA Medical News called the drugs a “lifesaver” for pregnant people with severe depression, obsessive-compulsive disorder, and panic attacks. “I wouldn’t change anything until we have more evidence,” he said of current practices.
Current American College of Obstetricians and Gynecologists (ACOG) practice guidelines recommend SSRIs as a first-line pharmacotherapy for perinatal depression and anxiety and say that drug therapy should be individualized based on prior treatment response.
However, the majority of panelists criticized SSRI treatment practices during pregnancy, outlining potential risks of the medications using language The New York Times described as “blunt, and, at times, alarming.”
Gingrich praised obstetrician-gynecologist Kay Roussos-Ross, MD, a consultant on the ACOG practice guidelines and director of the Perinatal Mood Disorders Program at the University of Florida Health, for voicing the strongest defense of SSRI treatment at the panel. Her remarks emphasized the risk of untreated mental illness for patients and their children.
An FDA spokesperson described the panel as part of the agency’s pursuit of “rigorous, evidence-based standards” in a comment to JAMA Medical News, but some professional groups expressed concerns about the discussion.
A press release from Postpartum Support International, an organization that represents people with perinatal mental health disorders, pointed out that most presenters lacked a background in this area of medicine, while a statement from ACOG’s president decried “outlandish and unfounded claims” about SSRIs and pregnancy by some panelists.
The State of the Evidence
Panel participants, independent experts, and ACOG alike stress the need for more research into how SSRIs affect maternal and fetal health. According to ACOG’s statement in response to the panel, a planned federal working group to study mental health medications including SSRIs in pregnant people is now delayed following cuts to the National Institutes of Health.
So far, no randomized clinical trials have been performed due in part to ethical concerns, such as whether pregnant participants should be assigned to intervention and placebo groups without their knowledge
“When pregnancy is involved, people understandably worry about the impact of that intervention on a developing fetus,” said Lindsay Lebin, MD, who specializes in reproductive mental health at the University of Colorado Anschutz and did not participate in the panel.
The strength of existing observational data supporting SSRI use could heighten these ethical issues because a trial with a control group would exclude some participants from receiving a treatment with a demonstrated benefit, noted ACOG’s chief of clinical practice, Christopher Zahn, MD.
But with observational studies, it’s challenging to isolate the effects of the medications from confounding factors, such as the underlying mental health condition the drugs are prescribed to treat.
A patient with a more severe mental health condition might pass the condition on to their children and might also be more likely to continue their medication regimen through pregnancy, explained Marlene Freeman, MD, a professor of psychiatry at Harvard Medical School and associate director of the Perinatal and Reproductive Psychiatry Program at Massachusetts General Hospital.
During the panel, Roussos-Ross observed that other drugs, such as hypertension and diabetes therapies, are often taken during pregnancy despite not having been studied in randomized clinical trials involving pregnant patients. “Mental health disorders are no different than medical disorders,” she said. “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.”
Others have different perspectives. “It’s a good idea to treat people who are depressed,” panelist David Healy, MD, told JAMA Medical News. “It’s not necessarily a great idea to give SSRIs.”
Healy, a psychiatrist who founded the UK-based company Data Based Medicine, says he prescribes SSRIs to patients but believes their benefits are overstated compared with other antidepressants. He also says their risks are minimized, including during pregnancy. Healy wants more detailed SSRI warning labels to support better patient and clinician decision-making.
Other panelists contacted by JAMA Medical News said that decisions about SSRI treatment are often justified by a faulty understanding that the drugs correct an underlying serotonin imbalance that causes depression.
The modern understanding of the causes of depression implicates multiple neurotransmitter systems and brain processes.
As for the risks, a 2018 meta-analysis of 29 cohort studies including more than 9 million births found a slightly increased risk of congenital malformations in infants exposed to SSRIs early in pregnancy, but the association diminished when people using SSRIs were compared only with other participants with psychiatric diagnosis. The authors concluded that the evidence “argues against a substantial teratogenic effect of SSRIs.”
Similarly, in a 2022 review of more recent research, Lebin and a coauthor found that compared with people with untreated psychiatric illness, the absolute risk of clinically relevant negative outcomes with SSRI use during pregnancy appeared to be low.
“SSRI antidepressants do not appear to be associated with an increased risk of major malformations or birth defects, and they do not appear to increase the risk of autism when you take into account maternal mental health and psychiatric disorders,” said Freeman, who is a coinvestigator for Massachusetts General Hospital’s National Pregnancy Registry for Psychiatric Medications, which monitors outcomes linked to antidepressants and other drugs. Freeman added that there are “many reassuring studies” about long-term neurodevelopmental consequences.
Lebin said the adverse effect most consistently linked with SSRI use during pregnancy is neonatal adaptation syndrome, which she noted occurs in 20% to 30% of infants exposed to the medications in utero. Symptoms can range from fussiness and irritability to feeding or breathing difficulties, but these tend to subside after a few days, she explained. She also pointed out that there are no long-term neurodevelopmental consequences of neonatal adaptation syndrome.
Meanwhile, untreated or undertreated depression carries its own risks during and after pregnancy, Kristina Deligiannidis, MD, director of Women’s Behavioral Health at Zucker Hillside Hospital, Northwell Health, wrote in an email. These include suicidal ideation, worse outcomes from conditions like gestational diabetes and hypertensive disorders during pregnancy, preterm birth, low birth weight, lactation issues, and impaired child cognitive and behavioral development. She added that clinical depression increases the likelihood that a pregnant person will smoke, consume alcohol, or use other harmful substances.
One meta-analysis found that pregnant people with severe or recurrent depression who discontinued antidepressants were more than twice as likely to relapse than people who continued them; however, there was no association when the analysis included people with more mild depression.
In a review of US mortality data from 2008 through 2017, researchers at the Centers for Disease Control and Prevention determined that 11% of the 421 pregnancy-related deaths they analyzed could be attributed to a mental health condition; 63% of these deaths were by suicide. Deaths associated with mental illness were more likely to be preventable than other pregnancy-related deaths.
Shaping Patient Decisions
Another recurring theme of the panel was that patients receive inadequate counseling before initiating SSRI treatment or continuing their regimen during pregnancy, which ACOG called a “false accusation.”
“To get to the point of counseling patients about antidepressant use in pregnancy, women first need to be screened and diagnosed with clinical depression,” wrote Deligiannidis, who was not involved with the panel. She cited a 2016 study that found that only half of people with antenatal depression were diagnosed in a clinical setting and only about 14% received any form of treatment, let alone medication.
The panel “mischaracterized” how clinicians and patients make decisions about psychiatric treatment during pregnancy, according to Freeman. She said clinicians aim to help women avoid postpartum mood and anxiety disorders and to help them meet the emotional and physical needs of caring for an infant.
“These are really carefully made, patient-centered decisions where we take into account the patient’s preferences, values, history of the psychiatric disorder, and responses to treatment,” Freeman added.
Lebin said clinicians typically would be inclined to continue the medication during pregnancy for patients with severe depression, for example, or for patients who have a history of relapsing when they discontinue. But, she said, for a patient who’s had one episode of mild depression, “it would be very reasonable to try tapering that person off of medication prior to them becoming pregnant.”
“SSRIs are a tool that we use, but they’re not the only tool,” she added. “And for many people, therapy and lifestyle interventions can be quite helpful, especially if their illness is on the milder side.”
Lebin credited organizations like the National Curriculum in Reproductive Psychiatry for improving education around perinatal mental health treatment in recent years for a wide range of clinicians beyond psychiatrists, nurse practitioners, and obstetrician-gynecologists.
Still, multiple panelists supported stronger or more comprehensive SSRI warning labels to address perceived gaps in patient education and clinician judgment. This could affect both patients’ perception of the drugs and payers’ willingness to cover treatment, Zahn said.
The FDA spokesperson declined to state whether the agency was considering policies to rein in SSRI use during pregnancy. But even without changes to how SSRIs are regulated or prescribed, critics warn that the panel could influence patients’ health decisions.
In its statement, ACOG’s president cautioned that the panel may “incite fear and cause patients to come to false conclusions that could prevent them from getting the treatment they need.”
“There is no risk-free choice when it comes to untreated mental health conditions in pregnancy,” Lebin said. “It’s a matter of finding the regimen that is going to keep a person well.”
Conflict of Interest Disclosures:
Dr Healy reported serving as an expert witness in one legal case about acetaminophen and autism spectrum disorder and another case about montelukast and neuropsychiatric disorders, both in the US. He also reported filing a petition with the FDA and European regulators about post-SSRI sexual dysfunction and that his website RxISK.org sponsors a prize for curing the condition.
Dr Freeman reported that the Massachusetts General Hospital National Pregnancy Registry is sponsored by Alkermes Inc, Dr. Reddy’s Laboratories Inc, Eisai Inc, Otsuka America Pharmaceutical Inc, Supernus Pharmaceuticals, and Teva Pharmaceutical Industries Ltd and was previously sponsored within the past 3 years by Aurobindo Pharma, AuroMedics Pharma, LLC, Sage Therapeutics, Sunovion Pharmaceuticals, Inc, and Johnson & Johnson/Janssen Pharmaceuticals, Inc. Dr Freeman reported receiving research funding through Massachusetts General Hospital from Sage Therapeutics, the National Institute on Aging, and the National Institute of Mental Health; consulting activities with Johnson & Johnson/Janssen Pharmaceuticals, Novartis, Neurocrine, Eliem, Sage Therapeutics, Everly Health, Brainify, Tibi Health, Relmada, Beckley Psytech, Brii Biotech, Reunion Neuroscience, and Vistagen; and educational activities with MGH Psych Academy, WebMD, Medscape, Pri-Med, Postpartum Support International, PRIME, HMP Global, and CME Institute.
Dr Deligiannidis reported consulting activities with GH Research, Sage Therapeutics, Biogen, Lipocine, Brii Biosciences, Gerbera Therapeutics, Neurocentria, and Reunion Neuroscience; serving in an unpaid role on the board of directors for the Marcé Society of North America; being a principal investigator for contracted research awarded to the Feinstein Institutes for Medical Research from Sage Therapeutics, Gerbera Therapeutics, Woebot Health, and Premier Healthcare; and receiving grants from the National Institutes of Health and royalties from a National Institutes of Health employee invention. No other disclosures were reported.
Dr. David Healy says
Directly underneath Lauren S’s SSRI and Pregnancy JAMA post this short comment on US Fertility Rates
JAMA Fertility 2025 Published Online: August 15, 2025 doi: 10.1001/jama.2025.10999
From 2023 to 2024, the number of births in the US rose 1% while the general fertility rate fell 1%, continuing a long-term decline, according to the US Centers for Disease Control and Prevention (CDC).
The CDC’s final birth data for 2024 reported approximately 3.628 million live births in 2024, up from 3.596 million the previous year. But during that time, the fertility rate decreased from 54.5 to 53.8 births per 1000 females aged 15 to 44 years.
Overall, US births have been trending downward. The report noted that from 2007 to 2023, the number of births has declined 16% and that from 2007 to 2024, the general fertility rate has declined 22%.
Younger women aged 15 to 34 years largely drove the decrease in birth rate from 2023 to 2024. The rate dropped 4% among teenagers and 3% for women in their early 20s. Rates also declined for women in their late 20s and early 30s, who have the highest birth rates. The rate stayed stable for women in their late 30s but increased 2% for women aged 40 to 44 years.
Dr. David Healy says
Jeff Lacasse posted this on X in response to JAMA
Just published: JAMA on SSRIs and pregnancy, at https://jamanetwork.com/journals/jama/fullarticle/2837827 – below is the statement I sent to the author. Compare with the published JAMA article and draw your own conclusions.
—
My presentation focused on the widespread social reputation of the SSRIs as normalizing agents correcting a known serotonergic deficit. On X, I posted my presentation along with a brief prelude which gives context. The PPT slide I referenced wasn’t shown on the stream of the presentation; it’s from our 2005 article arguing that SSRIs advertisements were misleading and suggesting that clinicians should not repeat drug company marketing slogans to patients as a scientific fact.
Since 2005, the number of prominent psychiatrists who publicly disavow the serotonin imbalance theory of depression and/or dismiss it as a debunked theory has grown substantially. However, patients are still told this explanation in real-world practice settings all the time.
How does this relate to SSRIs and pregnancy? As stated in my presentation, a woman may start SSRIs 5 to 15 years before deciding to get pregnant. If they believe the SSRIs simply normalize brain chemistry, they might consider the drug’s risk differently. A cautious woman planning to become pregnant might stop or reduce drinking coffee, eating sushi, or changing the cat box- but may not realize there are potential risks from taking SSRIs, if she believes the drug is normalizing her unbalanced brain chemistry.
Do women taking SSRIs deserve to know that these drugs can have demonstrable biological impacts on their baby, with ~30% manifesting poor neonatal adaptation syndrome (PNAS) at birth? Do they deserve to know that exposure to the mother’s SSRI could produce biological changes, including brain differences measured in individual neonates by MRI and fMRI?
I believe most women would prefer to be informed of these possibilities not only while pregnant, but far before, given that some people have great difficulty coming off the SSRIs once they start. To me, this is just being truthful, and supporting patients’ autonomy while strengthening the doctor-patient relationship.
As far as changes that I’d like to see regarding SSRI prescription practices: comprehensive, contextually-informed assessments at the very beginning of this process. Too often, it’s a busy PCP using a PHQ-9 and 5-10 minutes of predetermined questions to then prescribe an SSRI. By comparison, a psychologist could take hours to do a comprehensive assessment.
Most patients’ problems will be in the mild-to-moderate range and would respond to psychotherapy or other non-medication interventions first, as suggested by many existing treatment guidelines.
Ensuring women of child-bearing age are offered other options before proceeding to an SSRI would likely result in fewer women facing the dilemma of taking, and discontinuing from, SSRIs in pregnancy. And for those who decide to take SSRIs, they should be apprised of the risks and benefits, including those related to pregnancy. Either way, physicians and others should support the informed choices they make.