On Monday, July 21, a 10-member panel headed by Marty Makary, MD, MPH, commissioner of the FDA convened in Silver Spring, Maryland, to discuss the use of selective serotonin reuptake inhibitors (SSRIs) in pregnancy.

In his opening remarks, Makary questioned the broader impact of antidepressant use, suggesting that increased prescribing may be contributing to — rather than alleviating — the burden of depression in the US.

“We’re losing the broader battle of addressing mental health in the United States…the more antidepressants we prescribe, the more depression there is,” said Makary in his opening remarks.

The majority of the panelists argued against SSRI use in pregnancy, citing potential risks such as altered fetal brain development, congenital cardiac malformations, and postpartum hemorrhage.

The panel featured a range of perspectives, with several participants expressing concerns about potential risks associated with SSRI use during pregnancy.

“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,” said Adam Urato, MD, and chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Massachusetts.

David Healy, fellow of the Royal College of Psychiatrists and CEO of Data Based Medicine, in North Wales, said that SSRI use during pregnancy is linked to autism and other neurodevelopmental disorders, citing his own 2016 review published in the International Journal of Risk & Safety in Medicine and unspecified animal studies.

Other panelists questioned the overall effectiveness of antidepressants and expressed concern about the disproportionately high rates of SSRI prescriptions in women. Roger McFillin, PsyD, executive director of the Center for Integrated Behavioral Health, argued that some women’s emotional experiences are being pathologized, describing them as “gifts” rather than “symptoms of disease.”

Leading Medical Organizations Respond

However, leading medical organizations offer a different view. The National Curriculum in Reproductive Psychiatry (NCRP) noted in a release responding to the panel discussion that current data do not support a causal relationship between prenatal SSRI exposure and autism spectrum disorder.

In a statement the American College of Obstetricians and Gynecologists (ACOG) stated that “robust evidence” shows SSRIs are safe in pregnancy and that most do not increase the risk for birth defects.

ACOG pointed out that untreated depression in pregnancy can put patients at risk for substance use, preterm birth, preeclampsia, limited engagement in medical care and self-care, low birth weight, impaired attachment with their infant, and suicide.

In its statement ACOG noted also that “for pregnant people who need SSRIs, they are life-changing and lifesaving” adding that “mental health conditions are already the most frequent cause of pregnancy-related death.” Furthermore, a 2023 ACOG practice guideline recommends SSRIs as first-line treatment for perinatal depression.

Of the 10 panelists, Kay Roussos-Ross, MD, professor and director of the Perinatal Mood Disorders Program at the University of Florida in Gainesville, Florida, was the only one to emphasize the potential benefits of appropriately managed SSRI use during pregnancy and highlighted the serious risks associated with untreated perinatal depression.

“Not every single woman will need an antidepressant. But for those that do, this is life changing. And this is lifesaving,” said Roussos-Ross, noting that one of the leading causes of maternal death in the US is mental illness.

Call for Objectivity

Roussos-Ross emphasized the importance of examining data objectively and accounting for confounding factors such as maternal depression. “All of us can find a study that agrees with exactly what we think,” she said. When such factors are controlled for, research shows adverse outcomes associated with SSRI use in pregnancy are attenuated.

Panelist Jay Gingrich, MD, PhD, director of the Institute for Developmental Sciences at Columbia University Irving Medical Center in New York City, shared his latest research showing that children exposed to SSRIs in utero exhibited an overactive fear response compared with children whose mothers had lifetime depression but did not use SSRIs.

Reached for comment ahead of the panel discussion, Gingrich, who has studied this topic for over 20 years, acknowledged the “unequivocal” evidence of untreated perinatal depression as a problem, but said “there is limited, or no, evidence that SSRI treatment of the mother improves outcomes of their offspring — at least at the population level.” 

Panelists called for SSRI labels to be consistent within drugs of the same class and to be updated to include the risks laid out in the panel discussion.

Concerns Over Panel’s Claims

Commenting for Medscape Medical News, Nancy Byatt, DO, MS, MBA, a perinatal psychiatrist and member of the American Psychiatric Association Council on Women’s Mental Health who attended the event, said much of the panel’s discussion was inconsistent with scientific evidence and clinical guidelines.

She noted this “makes providing treatment much more challenging both for the providers serving patients and also for the patients who need the treatment themselves.” 

Also commenting on the discussion Sarah Nagle-Yang, MD, deputy executive director at Colorado Women’s Behavioral Health and Wellness and vice chair for quality at the Department of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, Colorado, who was not a participant but who attended the event, said that apart from Roussos-Ross, the panelists minimized the impact of perinatal mental health conditions.

“I’m very worried that the goal of this was to stigmatize the use of antidepressants during pregnancy and to exaggerate the risk. I worry that it will result in outcomes such as a black box warning that will misrepresent the science and dissuade people from treating a treatable illness during a critical time of their life,” Nagle-Yang told Medscape Medical News.

“Patients deserve honest communication that’s rooted in science, and I worry that this panel is moving us away from that goal,” she added.

‘Make Doctors Great Again’

A core issue that panelists and outside experts agreed on was a lack of randomized controlled trials testing SSRI use in pregnancy.

ACOG and NCRP advocated for the safe involvement of pregnant people in such trials. However, Roussos-Ross noted this current gap isn’t a reason to withhold SSRIs or other medications for which there is “robust observational data” from pregnant women.

A frequent talking point was that doctors don’t properly inform their patients about the risks of SSRIs during pregnancy, in part due to time constraints and inadequate drug labels. “Make doctors great again,” said Healy, who claimed that physicians are increasingly relying on drug labels, not their experience to make prescribing decisions.

In its release ACOG called it a “false accusation” that patients are deceived by doctors when it comes to the real effects of SSRIs.

When asked about the panel’s intent and potential outcomes, a spokesperson for the FDA told Medscape Medical News that such discussions are part of the agency’s “broader efforts to apply rigorous, evidence-based standards to ingredient safety and modernize regulatory oversight, thoroughly considering evolving science and consumer health.”