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.
Now, four months later, The New England Journal of Medicine has weighed in on the topic by publishing an opinion piece entitled “Untangling the Risks of Antidepressants in Pregnancy.”
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.
Studies show SSRIs in pregnancy are linked to miscarriage, birth defects, preterm birth, low birthweight, preeclampsia, postpartum hemorrhage, newborn complications, and long-term neurobehavioral problems. Twelve human MRI studies demonstrate impact on the developing brain.
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.
Thank you, Adam, for this response to the no-risk claim by the New England Journal of Medicine and the medical guilds (such as the APA, the American College of Obstetricians and Gynecologists) — a claim which has been uncritically reported by the mainstream media.
As you note, SSRIs “are powerful synthetic chemicals that alter the serotonin system, which is crucial to pregnancy and fetal development,” and the conclusion that they carry no risk in pregnancy is such an obviously idiotic assertion devoid of common sense that the abundant scientific research which debunks this no-risk claim is not even necessary for many people in the general public to grasp how ridiculous this claim is. That is my experience when I inform people about it.
The fallout from this no-risk claim will simply be an even larger erosion of trust for psychiatry and the medical establishment, who will be seen as completely in the pocket of drug companies.
The fallout for the mainstream media, which uncritically repeats this no-risk claim, will be an even larger erosion of trust, as it evidences a complete lack of common sense and utter journalistic incompetence in its lack of effort in actually examining the scientific research that debunks this no-risk claim.
The consequence for the general public, I am sorry to say, will be an even larger increase in anxiety and uncertainty as to who to trust when they are making life-changing decisions, as they clearly cannot trust professional medical guilds, medical journals, and the mainstream media.
The happy beneficiaries of this insanity are politician demagogues who gain power the more the general public is anxious and frightened.
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Thank you for your insightful comments.
I agree with you that the “no-risk claim” re: antidepressants in pregnancy is ridiculous and that it does erode trust.
There are vast numbers of studies now showing risk with SSRI use in pregnancy. These include, for example, 12 consecutive human MRI studies showing impact on the developing fetal brain – including smaller brain volumes.
The notion, from the medical establishment & mainstream media, that the antidepressants have profound chemical effects on the mom’s brain but pose no risk for the developing baby’s brain is particularly absurd.
Mainstream media & the medical establishment have brought this erosion of trust upon themselves. But, as you rightly point out, it does leave the public wondering where to turn.
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I would like to see all your sources,not just the MRI ones,those “dozens and dozens” of studies.you mention. I don’t know if what you say,all or part,is correct,but if you are concerned about trust,you need to provide more documentation.
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It’s amazing to me that people are open to understanding that any psychoactive substance, and any drug, from coffee and alcohol to Tylenol, may create a pregnancy risk and are to be avoided if possible. Yet many also believe that SSRIs are magical substances that have no effect on a developing fetus at all.
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Dr. Urato,
The situation is worse than you stated with regard to the PR battle over SSRIs in pregnancy. On social media doctors are frequently accusing SSRI skeptics of responsibility for maternal suicides by questioning SSRI use perinatally. The quote below is from OBGYN Jennifer Lincoln on Substack Notes:
“So much is wrong with what the FDA “expert” panel said regarding antidepressants and pregnancy. They very likely will have blood on their hands for the fearmongering they sowed today. Remember, death by suicide is a LEADING cause of death in pregnancy/postpartum.
What they did today was irresponsible and will undoubtedly contribute to more of these preventable deaths.”
https://substack.com/@drjenniferlincoln/note/c-137667216
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Like we needed another panel to address the potential and guaranteed adverse effects of “SSRIs.” The “system” relies on sociopaths, which apparently, there is an abundance.
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Dr. Arato, could you please send me the list of references for your article; for example, the 11 MRI studies to which you allude are not available on X, where you have posted about them. Thank you.
Robert T. Rubin, MD, PhD
Psychiatry Residency Teaching Faculty
Community Memorial Healthcare/Ventura County Medical Center
Distinguished Professor Emeritus
Department of Psychiatry and Biobehavioral Sciences
David Geffen School of Medicine at UCLA
[email protected]
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Dr. Rubin, Thank you for your comment. I just checked the link in my article to the 12 MRI studies and it is working.
The link goes to my “tweet” on X from June 23, 2025 and it discusses the Moreau, et al study (2023) https://pmc.ncbi.nlm.nih.gov/articles/PMC10140451/
That June 23 “tweet” also quote-tweets a prior post I did on May 21, 2025 which has the other 11 studies.
I have listed all 12 below for you. Let me know if you need anything else.
Thank you for your interest in this area.
#1 Zanni, G., van Dijk, M. T., Caffrey Cagliostro, M., Sepulveda, P., Pini, N., Rose, A. L., Kesin, A. L., Lugo-Candelas, C., Goncalves, P. D., MacKay, A. S., Iigaya, K., Kulkarni, P., Ferris, C. F., Weissman, M. M., Talati, A., Ansorge, M. S., & Gingrich, J. A. (2025). Perinatal SSRI exposure impacts innate fear circuit activation and behavior in mice and humans. Nature Communications, 16(1), 4002. https://doi.org/10.1038/s41467-025-58785-4
#2 Moreau, A. L., Voss, M., Hansen, I., Paul, S. E., Barch, D. M., Rogers, C. E., & Bogdan, R. (2022). Prenatal selective serotonin reuptake inhibitor exposure, depression, and brain morphology in middle childhood: Results from the ABCD study. Biological Psychiatry: Global Open Science, 3(2), 243–254. https://doi.org/10.1016/j.bpsgos.2022.02.005
#3 Salzwedel, A., Chen, G., Chen, Y., Grewen, K., & Gao, W. (2020). Functional dissection of prenatal drug effects on baby brain and behavioral development. Human Brain Mapping, 41(15), 4123–4135. https://doi.org/10.1002/hbm.25158
#4 Koc, D., Tiemeier, H., Stricker, B. H., Muetzel, R. L., Hillegers, M., & El Marroun, H. (2023). Prenatal antidepressant exposure and offspring brain morphologic trajectory. JAMA Psychiatry, 80(12), 1208–1217. https://doi.org/10.1001/jamapsychiatry.2023.3161
#5 Campbell, K. S. J., Williams, L. J., Bjornson, B. H., Weik, E., Brain, U., Grunau, R. E., Miller, S. P., & Oberlander, T. F. (2021a). Prenatal antidepressant exposure and sex differences in neonatal corpus callosum microstructure. Developmental Psychobiology, 63(6), e22125. https://doi.org/10.1002/dev.22125
#6 Rotem-Kohavi, N., Williams, L. J., Muller, A. M., Abdi, H., Virji-Babul, N., Bjornson, B. H., Brain, U., Werker, J. F., Grunau, R. E., Miller, S. P., & Oberlander, T. F. (2019a). Hub distribution of the brain functional networks of newborns prenatally exposed to maternal depression and SSRI antidepressants. Depression and Anxiety, 36(8), 753–765. https://doi.org/10.1002/da.22906
#7 Rotem-Kohavi, N., Williams, L. J., Virji-Babul, N., Bjornson, B. H., Brain, U., Werker, J. F., Grunau, R. E., Miller, S. P., & Oberlander, T. F. (2019b). Alterations in resting-state networks following in utero selective serotonin reuptake inhibitor exposure in the neonatal brain. Biological Psychiatry: Cognitive Neuroscience and Neuroimaging, 4(1), 39–49. https://doi.org/10.1016/j.bpsc.2018.08.004
#8 Lugo-Candelas, C., Cha, J., Hong, S., Bastidas, V., Weissman, M., Fifer, W. P., Myers, M., Talati, A., Bansal, R., Peterson, B. S., Monk, C., Gingrich, J. A., & Posner, J. (2018). Associations between brain structure and connectivity in infants and exposure to selective serotonin reuptake inhibitors during pregnancy. JAMA Pediatrics, 172(6), 525–533. https://doi.org/10.1001/jamapediatrics.2017.5227
#9 Podrebarac, S. K., Duerden, E. G., Chau, V., Grunau, R. E., Synnes, A., Oberlander, T. F., & Miller, S. P. (2017). Antenatal exposure to antidepressants is associated with altered brain development in very preterm-born neonates. Neuroscience, 342, 252–262. https://doi.org/10.1016/j.neuroscience.2016.11.025
#10 Jha, S. C., Meltzer-Brody, S., Steiner, R. J., Cornea, E., Woolson, S., Ahn, M., Verde, A. R., Hamer, R. M., Zhu, H., Styner, M., Gilmore, J. H., & Knickmeyer, R. C. (2016). Antenatal depression, treatment with selective serotonin reuptake inhibitors, and neonatal brain structure: A propensity-matched cohort study. Psychiatry Research: Neuroimaging, 253, 43–53. https://doi.org/10.1016/j.pscychresns.2016.05.004
#11 Salzwedel, A. P., Grewen, K. M., Goldman, B. D., & Gao, W. (2016). Thalamocortical functional connectivity and behavioral disruptions in neonates with prenatal cocaine exposure. Neurotoxicology and Teratology, 56, 16–25. https://doi.org/10.1016/j.ntt.2016.05.009
#12 Knickmeyer, R. C., Meltzer-Brody, S., Woolson, S., Hamer, R. M., Smith, J. K., Lury, K., & Gilmore, J. H. (2014). Rate of Chiari I malformation in children of mothers with depression with and without prenatal SSRI exposure. Neuropsychopharmacology, 39(11), 2611–2621. https://doi.org/10.1038/npp.2014.114
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Prenatal exposure aside, I can’t help but wonder about to the development of a child in terms of affect regulation, expectations from others, confidence to explore, attentional style and stress reactivity whose primary care giver is emotionally and responsively muted due to SSRI use.
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Modern machinery for birthing human beings might lead anyone to wonder how in the world the species ever reproduced for hundreds of thousands of years prior to the past couple of centuries of industrial medicine. Here as elsewhere with market colonization of people as patients captive to medical consumerism, there is a multitude of artificial interventions manufactured for what used to be something natural (recalling, for example, witch hunts on midwifery to the advantage of medical monopoly).
Concentrating on one chemical cocktail alone like so-called antidepressants, reduced further to focus on serotonin, is an exercise of concealing the forest for the trees, or rather one leaf of a tree considering how so much fuss is made only to result in appeal for no more than minutiae like proper fine-print warnings for drugs still being pushed by doctors. While these same ‘antidepressants’ have for decades been known to cause depression, that’s no concern to expertise whose principal purpose is to incessantly debate disconnected details of data internal to bizzness as usual beyond the purview of the public, who are like laity to theologians serving in the ranks of religious rule by superstition called science arguing over how many germs can stand on the head of a needle, or which rigged animal studies are relevant to humans.
As simply proven by the staggering proliferation of pharmaceutical poisons for nearly everything natural to the human condition, the basic bizzness logic is to pathologize life for profit (a system which leads to a heavy death toll every year). Accordingly, why not start at the beginning of life, just to ensure lifelong customers? Mother and child thus become subject to all sorts of lucrative inventions largely driven by fear-mongering, like so many pseudoscientific tests to determine concocted statistical risks to health, particularly drawing on dubious if not disproven and downright fraudulent genetic research.
Meanwhile, real risks, downplayed among the X-rays, MRIs, ultrasounds and all the chemical and surgical interventions deemed necessary for ‘wellness’, are run on the targeted patient population for the money racket. And woe unto any conscientious objector to (‘safe and effective’) criminal corruption in that most sacred pseudoscience of vaccinology, sure to be demonized for not only ‘misinformation’ but ‘disinformation’ when stating the obvious, confirmed by innumerably suppressed studies, like the incontrovertible correlation between increases in vaccination and all manner of chronic disease, including complications from heart defects to ‘autism’ now magically made natural as ‘neurodiversity’. Nevertheless, even if you’ll never see some surgeon general’s warning for it, the big lie remains reality: medicine is dangerous to your health.
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Dr. Urato, I watched the entire panel discussion on SSRIs and pregnancy and thought that you presented compelling evidence for all of us to consider. But the paradigm of depression being caused by a chemical imbalance which drugs can “fix” has a profound grip and even hypnotizing effect on our society. Sometimes scientific proof–which absolutely should be enough to convince people–needs to be accompanied by a new story to explain depression. It’s so much harder to get people to really look at their lives and find the root causes for their pain. But if we could talk about depression as being a warning light that needs our attention rather than messed up brain chemicals that need rebalancing we might have a chance to shift the paradigm. To me, one of the most difficult parts of the problem is helping women discontinue SSRIs once they are pregnant. Our paradigm shift needs to happen much sooner. Thank you for your work and keep fighting!
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Thank you for this important information. It is absurd to think that depression, a condition that has no known pathophysiology, is a greater problem than intrauterine exposure to a chemical that disrupts a developmentally sensitive system.
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Follow the money
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Some months back, I wrote to the NEJM explaining as well as I felt I could (I offered ten points and claimed I could add a further 20 or so to substantiate my assertion that physical pain = sensation + the emotion of fear/alarm/aversion) why we (noncephalopods, you know) could not and do not have peripheral pain-receptors or “nociceptors:” No fear, no pain etc., and that any definition of a supposed “nociceptor” as “a nerve ending sensitive to tissue-damaging or potentially tissue-damaging stimuli” applies, of course, to absolutely any sensory nerve ending, at all. Obvious, eh?
The NEJM apparently just did not get it. I mean, not even enough to offer to publish so much as a lowly letter-to-the-editor.
I guess the NEJM, like so many other well-, if not over-educated, parties with whom I have attempted to share this priceless insight, was just too depressed to get it?
I expect that, perhaps in a few years’, or maybe in a few months’ time, when the NEJM is no longer so depressed, the NEJM will get it, and will then also get that one may lose one’s sense of humor and become depressed for just about any number of very excellent endogenous and exogenous reasons in the world – OTHER than that single bogus reason – that one can become depressed because “one suffers from depression,” this being tantamount to diagnosing that one is jaundiced because “one suffers from jaundice,” only maybe stupider, still.
Soon, the NEJM may have so regained its sense of humor that, rather than blushing at its stupidity, it laughs to think that it could ever have fallen for the Monty Pythonesquely stupid suggestion that hopelessness/humorlessness can be caused by “major depression” rather than being “major depression.”
“She’s a witch:”
https://www.youtube.com/watch?v=zrzMhU_4m-g
In fairness, though, the blindingly obvious can be the hardest thing in the world to see, of course, and sometimes for blindingly obvious reasons, too, and, when fortunes and careers and reputations are at stake, and when any degree of wilful blindness is there to back it up, then genuine, obviousness-induced blindness, emperors’ invisible clothes may remain seductively easier to see and to describe in the very greatest of detail – in order to blind others with “science.”
“It’s Just a Ride”
https://www.youtube.com/watch?v=KgzQuE1pR1w
That the rest of Medicine does not deride, decry and disavow psycho pharmacology since homosexuality was inserted into and subsequently removed from DSM’s, or even, failing that, since “ADD” and “ADHD” became bonafide “mental disorders” along with all their other psychiatric hallucinations/delusions leads me to wonder if even a thorough debunking of “nociceptors,” when it comes about, will provoke a double take on all supposed disorders “of personality” and “of mind.”
Thank you, Ms Cosmos, for hiding such things from the learned and the humorless, and for revealing them to…comedians.
Thank you, Adam and MIA, for the wonderful work!
Tom.
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Thanks Dr. Urato. All great points made. Anyone who knows how to read and interpret medical research can deduct the same reasoning you have made from it. Fortunately for big pharma, most Americans cannot and therefore take the word of our medical organizations. We did not do decades of animal research so that we could treat pregnant rats with SSRI’s safely. Thank you for your dedication to this issue. I wrote my grad school thesis on the safety of SSRI’s in pregnancy and came across all of the studies that you mention and was shocked! Yet, I continued to listen to my doctors and tried to taper off of my SSRI (20 year use) during pregnancy, which led me to a miscarriage and disabling protracted withdrawals for the last 3 years. I actually worked in OBGYN prior to this happening and did rounds with you a few times! Thank you for spreading this to the public and providing true informed consent to pregnant women.
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I’d like to add that what Dr. Urato and others are calling for is simply stronger warning labels and patient education regarding the risks of SSRIs during pregnancy. So people can make fully informed choices. Apparently this is beyond the pale to the medical establishment.
Instead, we get biased articles like this from KFF Health News: https://kffhealthnews.org/news/article/fda-antidepressants-risks-pregnancy-mothers-ssri-mental-health/.
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