Following the FDA Panel on SSRIs and pregnancy, there have been 25 at least 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 medica journals which will be posted after this post.
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.
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