A group of outside experts convened Monday by Food and Drug Administration Commissioner Martin Makary questioned the benefits and safety of antidepressant use in pregnant women and called for stricter labeling of the drugs.

The panel raised concerns specifically about the risks of selective serotonin reuptake inhibitors, a common type of antidepressant that Health and Human Services Secretary Robert F. Kennedy Jr. has criticized as overprescribed.

No consensus emerged from Monday’s meeting, nor did FDA officials indicate any action they plan to take next.

The panel followed a similar pattern as one hosted to discuss hormonal menopause therapy Thursday. Many of the experts invited to attend held similar views as each other, generally opposing SSRI use in pregnant women.

Opening Monday’s meeting, Makary said that while SSRIs can be effective, they can also pose risks. He also raised concerns about how widespread their use has become, drawing comparisons to rising rates of other conditions.

“The more antidepressants we prescribe, the more depression there is. The more insulin we prescribe, the more diabetes there is,” Makary said. “I’m not suggesting that these medications, or any medications, are causative of mass explosions of disease from an epidemic standpoint, but we have to start talking about root causes.”

SSRIs are typically prescribed for depression, but can also treat anxiety and other psychological conditions. The class of drugs includes well-known brands like Lexapro, Prozac and Zoloft. 

Physicians typically adopt a personalized approach when treating mental health disorders during pregnancy, taking into account factors like mental health history, which medication to recommend and any potential risks.

While there is some concern of neurodevelopmental disorders in newborns following antidepressant use during pregnancy, other research has found evidence for such a link to be weak and unlikely to be causally related to the medicines.

Depression during pregnancy can also lead to complications, including postpartum depression, if untreated. And despite its prevalence, depression in pregnant women is often undertreated or untreated altogether.

Some of the panel experts even argued against the benefits of SSRIs directly. “It's really important to appreciate that there is very little evidence that antidepressants have actual benefits in depression,” claimed Joanna Moncrieff, a practicing psychiatrist and professor of critical and social psychiatry at University College London, who attended virtually.

Others on the 10-person panel agreed that better warnings were needed for the drugs, but gave different reasons for why.

Adam Urato, chief of maternal fetal medicine at MetroWest Medical Center in Massachusetts, said SSRIs have been linked to various pregnancy complications and birth defects in both animal and human studies, and called for better risk information.

“What are we waiting for before we warn the public?” Urato said.

Josef Witt-Doerring, a former FDA official and now a psychiatrist at TaperClinic, which helps people quit psychiatric drugs, highlighted how stopping SSRI treatment can be difficult for some. Kennedy has talked often about this issue, falsely claiming that SSRIs can be as difficult to quit as heroin.

Stopping antidepressant treatment can cause withdrawal symptoms such as nausea, headaches or mood swings that can range in severity depending on the length of treatment.

“I think for a long time we've taken a lot of pride in this country about being the epicenter of pharmaceutical development,” Witt-Doerring said. “But we should also take a lot of pride in informing the people who live here, our citizens, about the risks of these medications.”

One panelist, Kay Roussos-Ross, advocated for continued use of SSRIs in pregnant women.

“All of us can find a study that agrees with exactly what we think,” said Roussos-Ross, who is a professor at the University of Florida College of Medicine and director of a perinatal mood disorders program there. “But we need to look at the data very objectively, and think about all the confounding factors that also affect outcomes in infants, fetuses and children,” she said.

Roussos-Ross said the panel should focus on how the risks of treatment balance against the risks of untreated depression in pregnant women, and argued medications should remain available for those who need them.

“Not every single woman will need an antidepressant, but for those that do, this is life-changing, and this is lifesaving,” Roussos-Ross said.

Roussos-Ross added that more research should be done in pregnant women, a group that has been neglected in clinical trials due to fear of harm.