I am a maternal-fetal medicine physician who has been taking care of pregnant women for 30 years. I counsel patients regarding medications in pregnancy every day and I have been writing and lecturing on antidepressants and pregnancy for decades. I frequently discuss this issue on podcasts, including
this recent one on Mad in America.
On July 21, 2025, the FDA held an
expert panel discussion on SSRI antidepressants and pregnancy, in which I participated. The panel highlighted a substantial body of scientific evidence showing that SSRIs are associated with pregnancy complications and altered fetal development. Several panelists, including myself, encouraged the FDA to strengthen the pregnancy warnings on these drugs.
The reaction from the media and the professional medical societies (e.g., the American College of Obstetricians and Gynecologists and the American Psychiatric Association) was quick and predictable. Story after story came out every few days with the same basic structure. They criticized the panel for “misinformation” and they emphasized the risks of depression itself, the supposed safety of the drugs, and the purported benefits. In particular, they downplayed the chemical exposure/chemical harm aspect of the issue and minimized risks of SSRIs to the pregnant mom and her developing baby.
The article is written by three researchers, two of whom report
significant financial ties to the pharmaceutical industry. The article focuses on two main complications—congenital heart defects and autism spectrum disorder. The central argument of the piece is that early studies showed SSRIs to be associated with heart defects and autism but that these studies suffered from confounding by indication: meaning that it was really the depression causing these problems rather than the antidepressants. With better statistical adjustment of the studies over the years, these associations with harm have been rendered not significant and we can now be reassured that antidepressants may not carry any risk in pregnancy.
I think this article speaks volumes about the position that the medical establishment has taken on this issue and how pregnant women and the public have been misled about antidepressants and pregnancy over the past four decades. My concerns are as follows:
1. The article ignores basic science and common sense. If serotonin plays a crucial role in pregnancy and fetal development (which it does), and if SSRIs alter the serotonin system (& they do), then SSRIs must disrupt pregnancy & fetal development.
2. The article completely disregards decades of animal studies because they “do not translate reliably to human pregnancy.” This is absurd, misleading, and disrespectful to the researchers (and animals) involved in these studies. These randomized controlled
animal studies consistently show SSRIs are linked to pregnancy complications and alterations in fetal development.
The overarching goal of doing animal research in this area is NOT to figure out if SSRIs will affect rats, mice, and sheep. The 40-plus years of extensive animal research on SSRIs in pregnancy has been done to help determine how these drugs will impact human pregnancy. The notion that the authors of this NEJM piece intend to dismiss this research with a wave of the hand is outrageous.
3. The word “chemical” does not appear even once in the article. There is no recognition whatsoever that SSRI use in pregnancy represents a chemical exposure with chemical harms to mom and baby. The pharmaceutical industry has done a masterful job creating a halo of goodness around their products: the public has been told to “take our medications”—which are just assumed to improve health. But, at the end of the day, these medications are synthetic chemical compounds, which are manufactured in chemical facilities, and chemicals have consequences for moms and babies.
4. The authors of this NEJM opinion piece are paid by drug companies, including GSK, Takeda, UCB, Hoffman-La Roche, Genentech, Moderna, and Vertex. Scientific authors generally argue that money does not influence them and one never knows exactly what is in the heart and mind of a given researcher who is funded by Pharma.
However, simple common sense and an overwhelming amount of
research suggests that money does, in fact, influence behavior (from regulators and researchers, to politicians and prostitutes). And, it’s indisputable that such payments create the perception of bias in the public’s mind. And this doubt about the motivations of the experts is harmful. Pregnant women and the public deserve to hear from experts untainted by Pharma cash.
5. In human research,
study after
study shows poorer pregnancy outcomes in the SSRI group—exactly what would be expected from chemicals disrupting the serotonin system. And many of the complications are precisely those seen in the animal studies. This article attributes these human results to confounding by indication. The authors essentially reassure us that over the years, epidemiologists (many of whom receive Pharma funding) have figured out how to adjust and correct the actual raw data to make any evidence of harms become not statistically significant.
Yet, the explanation that all of the pregnancy complications we see in the SSRI group are due to confounding by indication falls short. First, information about the association between depression and adverse pregnancy outcomes and adverse outcomes in the offspring comes from low to moderate quality studies. Second, in studies of this, the observed effects of depression are small (and often nonexistent). For example, when the Institute of Medicine studied causes of preterm birth, they did NOT find that depression causes preterm birth. Third, many studies do control for depression and numerous other confounding factors and they still find increased risks in the SSRI group. Finally, and this is very important, the adjustment for confounding in the studies often appears to be done in a mysterious way, in which the excess risks in the SSRI group are made to suddenly disappear and assigned to being due to the disease. It’s sort of statistical mumbo jumbo.
And, at the end of the day, it’s essential to realize that in study after study, the SSRI group is having worse pregnancy outcomes. This flies in the face of the notion that the meds cure the disease, which then results in improved obstetrical results. This is simply not what the data shows.
6. The authors fail to clearly identify ANY risk at all of SSRI use in pregnancy. They do mention that some studies have shown some associations with complications. But they never make it clear that there is a substantial amount of scientific agreement in this area that SSRI antidepressants are linked to complications for moms and babies.
The current drug labels are not sufficient, but at least these labels do warn about the link between SSRI use in pregnancy and postpartum hemorrhage, poor neonatal adaptation, and persistent pulmonary hypertension of the newborn. This article doesn’t even do that. A reader could walk away from this article concluding that antidepressants have no chemical impact on the pregnancy or developing baby. And this is from an article that purports, with its title, to be “untangling the risks of antidepressants in pregnancy.”
7. Their concluding message “that treatment with SSRIs carries little or no risk” is beyond the pale. The idea that the SSRIs—powerful synthetic chemicals that alter the serotonin system, which is crucial to pregnancy and fetal development—may carry no risk in pregnancy is so outrageous and so utterly unfair to readers and pregnant women.
These authors and the NEJM are failing to give a proper warning on the use of antidepressants in pregnancy. History, and the affected moms & babies, will judge them poorly.
The bottom line continues to be that pregnant women and the general public need proper information. This NEJM opinion piece and the media coverage of this topic are further evidence that the FDA must strengthen the warnings re: antidepressants in pregnancy.
