FDA panel convenes on SSRIs and pregnancy amid ongoing debate over risk, efficacy

FDA panel convenes on SSRIs and pregnancy amid ongoing debate over risk, efficacy | Image credit: Contemporary OB/GYN

The US Food and Drug Administration (FDA) convened a public expert panel to discuss the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy, highlighting a contentious and complex issue that affects millions of women in the United States. The panel brought together perinatal psychiatrists, developmental biologists, epidemiologists, obstetricians, and mental health experts to assess the current state of evidence on SSRIs, including their risks, benefits, and regulatory implications.

FDA Commissioner Marty Makary, MD, MPH, opened the session by acknowledging that “nearly 1 in 4 middle-aged women are on an antidepressant, and up to 5% of women in pregnancy are on an antidepressant.” While recognizing the potential benefit of SSRIs, he cautioned that the broader picture of mental health in the United States has not improved despite increasing prescriptions. “The more antidepressants we prescribe, the more depression there is,” he said, adding, “We have to start talking about root causes.”

Anick Bérard, PhD, professor of Perinatal Epidemiology, University of Montreal, faculty of Pharmacy, and CHU Ste-Justine in Montreal, and adjunct professor at the Faculty of Medicine, Université Claude Bernard, stated that depression and anxiety in pregnancy are prevalent and require treatment. “Untreated depression and anxiety during pregnancy has been shown to be associated with an increased risk of postpartum depression,” she said. She emphasized the complexity of risk-benefit analysis for antidepressant use in pregnancy and noted that the absolute risk of outcomes such as miscarriage or autism remains low, even if relative risk appears elevated in some studies.

Jay Gingrich, MD, PhD, director, Institute for Developmental Sciences, and professor of Developmental Psychology (in Psychiatry), Columbia University Irving Medical Center, presented findings from large-scale studies linking in utero SSRI exposure to increased rates of adolescent depression. “Until recently, there’s really never been any attempt to study whether this treatment of the mother actually improves outcomes in the offspring,” he noted. Gingrich also emphasized that serotonin plays a different developmental role in utero than in adults, acting as a neuromodulator that influences organ and neural development.

Adam Urato, MD, chief of Maternal-Fetal Medicine at MetroWest Medical Center, called for stronger FDA warnings. “Patients regularly tell me that essentially the only counseling they received is that SSRIs don’t affect the baby or cause complications. This is simply not accurate,” he said. He cited data from animal studies and human imaging studies to assert that SSRIs alter fetal brain development. “The SSRIs can be very difficult to get off of, so the time to think about these things is long before pregnancy,” he added.

Some panelists, such as Kay Roussos-Ross, MD, took a different position. “One in 5 women will have a perinatal mood disorder,” she said. “Psychotherapy and SSRIs are tools that we have… Treating mental illness in pregnancy is not a luxury. It’s a necessity.” Roussos-Ross cited guidelines from multiple professional societies and argued that the risks of untreated mental illness often outweigh those of SSRI exposure, especially when factoring in increased rates of preterm birth, poor prenatal care, and maternal suicide.

Roussos-Ross is a professor and chief in the Division of Academic Specialists in General Obstetrics and Gynecology, and director of the Perinatal Mood Disorders Program in the Department of Obstetrics and Gynecology and Psychiatry at the University of Florida College of Medicine.

However, several participants questioned the foundational premise of SSRI efficacy. Joanna Moncrieff, MD, professor of Critical and Social Psychiatry at University College London and practising psychiatrist, stated, “There is very little evidence that antidepressants have actual benefits in depression.” She argued that perceived improvements may stem from nonspecific psychoactive effects rather than the correction of a biochemical imbalance.

Multiple speakers also criticized the prevailing “chemical imbalance” narrative. Jeffrey Lacasse, PhD, MSW, associate professor, College of Social Work, Florida State University, noted, “88% of Americans believe that antidepressants correct chemical imbalances, despite no conclusive scientific basis.” He suggested this belief contributes to overprescribing, including among women of reproductive age.

Michael Levin, PhD, distinguished professor, Department of Biology and Director of the Allen Discovery Center at Tufts University, provided evidence that serotonin signaling plays a critical role in early embryonic patterning and organ asymmetry. “Manipulating its use by cells with SSRIs is very, very likely to cause certain kinds of defects,” he said, referencing experiments in frogs and chicks.

In addressing regulatory implications, a psychiatrist at Taperclinic and former FDA medical officer Josef Witt-Doerring, MD, highlighted that even known risks like neonatal withdrawal and cardiac malformations are inconsistently addressed across SSRI drug labels. He proposed more accessible patient education, such as QR codes on prescription bottles linking to FDA-approved risk summaries.

The panel did not reach consensus on new regulatory action, but many agreed that greater transparency, improved labeling, and expanded access to nonpharmacologic interventions are needed. “The key is information,” said Urato. “Never before in human history have we chemically altered developing babies like this… without any real public warning.”

The FDA has not yet announced whether it will revise current SSRI labeling or issue new guidance. However, the agency indicated it would consider the panel’s input in evaluating potential policy updates.

Reference:

FDA. FDA Expert Panel on Selective Serotonin Reuptake Inhibitors (SSRIs) and Pregnancy. FDA July 21, 2025. Accessed July 21, 2025.