FDA Faces Pressure Over Controversial Antidepressant Warnings for Pregnant Women
A push for stricter warnings on antidepressants during pregnancy has sparked debate among medical experts. Dr. Adam Urato, a maternal-fetal medicine specialist, is urging the FDA to add a boxed warning to SSRIs, claiming unproven risks like miscarriages and fetal brain abnormalities. The proposal has drawn criticism from psychiatrists who warn it could lead to untreated depression in millions of women.
Over 26 million U.S. women—more than 15%—currently take medication for depression, according to federal data. The FDA must now respond in writing to Urato's petition, as required by law for all citizen submissions.
Dr. Urato's campaign gained unexpected support last autumn when Dr. Tracy Beth Hoeg, the FDA's top drug regulator, presented his work as her own to senior officials. This raised concerns about her neutrality, especially given her history of opposing public health measures like masking and vaccine mandates during the pandemic. Despite these doubts, Hoeg is now accelerating the review of Urato's petition while also attempting to hire him as a full-time FDA employee.
The FDA has long set a high bar for drug warnings, requiring peer-reviewed studies, post-marketing data, and clear proof of risk. Past petitions for extensive labels—such as those for antidepressants in 2004 and statins in the 2010s—were rejected for lacking robust evidence. Critics argue Urato's claims rely on anecdotal reports rather than controlled research.
Dr. Jennifer Payne, a reproductive psychiatrist, warned that a black box warning could deter doctors and patients from using antidepressants when needed. Outside experts share her concern, pointing to the dangers of untreated depression, which can include severe health risks for both mother and child.
The debate comes as Urato joins the CDC's vaccine advisory panel, recently restructured to include voices sceptical of vaccines. His dual role in pushing for drug warnings and shaping vaccine policy has further fuelled scrutiny of his influence.
The FDA's decision on Urato's petition will affect millions of women who rely on SSRIs. If approved, the warning could reshape how antidepressants are prescribed during pregnancy. If rejected, it would align with the agency's past insistence on rigorous scientific proof before mandating major label changes.
