FDA Panel Weighs Risks, Benefits of SSRI Use During Pregnancy

An FDA panel met this week to discuss the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy. The group, made up of 10 independent experts, concluded that more research is needed to determine if the benefits of SSRIs truly outweigh the risks for pregnant women due to potential side effects.¹

The risk of untreated depression for pregnant women can cause adverse outcomes, which can include relapse in mood symptoms, suicide, and overdose death. | Image Credit: pressmaster - stock.adobe.com

“Some estimates have that nearly 1 in 4 middle-aged women are on an antidepressant,” Marty Makary, MD, MPH, commissioner of the FDA, said in the opening remarks of the panel.¹ “Up to 5% of women in pregnancy are on an antidepressant.”

Makary said that while antidepressants can be an effective treatment for depression, the US is “losing the broader battle of addressing mental health,” and in some instances is even going backwards.¹

“SSRIs may be unique because serotonin may have an interaction with the physiology of a woman and a woman who is pregnant,” Makary said.¹ “Serotonin may play a crucial role in the development of organs of a baby in utero, specifically heart, brain, and even the gut. SSRIs have also 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.”

During the discussion, some of the panelists said the potential risks to the infant could include behavioral-related risks, such as attention deficit-hyperactivity disorder, depression, and anxiety. Kay Roussos-Ross, MD, from the University of Florida’s College of Medicine in Gainesville, discussed the most prevalent risk between SSRIs and pregnancy, which is neonatal adaptation syndrome.¹

An author of an article published by Johns Hopkins Medicine did note that approximately 30% of babies with mothers who took SSRIs will experience neonatal adaptation syndrome, causing jitteriness, irritability, and respiratory distress. However, in most cases, the symptoms resolve on their own. Neonatal adaptation syndrome can also occur in babies whose mothers do not take SSRIs.²

Other studies have shown SSRIs could cause persistent pulmonary hypertension, but in a large study with over 3.8 million participants, there was no increased risk. Specifically, paroxetine showed connections with cardiac defects in early studies, but more recent studies showed no link. The authors said early studies did not account for smoking, obesity, and other risk factors of depression.²

Roussos-Ross was one of the few panelists to highlight the risk of untreated depression for pregnant women, which can include relapse in mood symptoms, suicide, and overdose death.¹

In the Johns Hopkins Medicine article, the author states that women should balance their mental health needs during pregnancy. Generally, they stated there is no need to taper off medications during pregnancy because antidepressants are not known to cause birth defects. Additionally, untreated mental illness poses a risk to the developing fetus, causing preterm birth or lower birth weights.²

Some of the panelists discussed a greater uptake of alternative treatment options, including psychotherapy and novel therapies. Adam Urato, MD, from the MetroWest Medical Center in Massachusetts, said there should be boxed warning labels on SSRIs, with others agreeing and stating that the labeling should be patient friendly.¹

However, some panelists made controversial claims, which were rejected by the American College of Obstetricians and Gynecologists. One such claim from Joanna Moncrieff, MD, from the University College of London, stated that in a clinical trial antidepressants were “barely distinguishable from placebo.”^1,3

In an article published in The Lancet, the authors stated that in 28,552 citations—including 522 trials and 116,477 patients—all antidepressants were more effective than placebo. The differences in odds ratios between antidepressants ranged from 1.15 to 1.55 for efficacy and 0.64 to 0.83 for acceptability.⁴

“For pregnant people who need SSRIs, they are life-changing and lifesaving. Mental health conditions are already the most frequent cause of pregnancy-related death. 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,” Steven J. Fleischman, MD, MBA, FACOG, president of ACOG, said in the statement.³ “Patients who choose to continue taking SSRIs during pregnancy with the support of their ob-gyns do so following counseling on the risks and benefits that includes discussion of the data and consideration of their own needs, values, and priorities.”

READ MORE: Women's Health Resource Center

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REFERENCES

1. FDA. FDA Expert Panel on Selective Serotonin Reuptake Inhibitors (SSRIs) and Pregnancy. July 21, 2025. Accessed July 24, 2025. https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-selective-serotonin-reuptake-inhibitors-ssris-and-pregnancy-07212025

2. Johns Hopkins Medicine. Antidepressants and Pregnancy: What to Know. Accessed July 24, 2025. http://hopkinsmedicine.org/health/wellness-and-prevention/antidepressants-and-pregnancy-tips-from-an-expert

3. The American College of Obstetricians and Gynecologist. ACOG Statement on the Benefit of Access to SSRIs During Pregnancy. News release. July 21, 2025. Accessed July 24, 2025. ws/news-releases/2025/07/statement-on-benefit-of-access-to-ssris-during-pregnancy

4. Cipriani A, Furukawa TA, Salanti G, et al. Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis. Lancet. 2018;391(10128):1357-1366. doi:10.1016/S0140-6736(17)32802-7