The Food and Drug Administration’s top drug regulator, Dr. Tracy Beth Hoeg, is working to hire a researcher and friend, Dr. Adam Urato, a maternal-fetal medicine specialist and critic of antidepressant safety, who is pressing the FDA to add a boxed warning to SSRIs about unproven pregnancy risks. Urato’s petition says the medications can cause pregnancy complications, including miscarriages and fetal brain abnormalities that may lead to autism and other disorders in children. That proposed labeling change has become a top priority for Hoeg, who regularly consults with Urato and is working to bring him on as a full-time FDA employee.
Within the agency, Hoeg’s close relationship with Urato is viewed as a clear conflict of interest that, under normal FDA standards, would result in her recusing herself from any work on the petition. But Hoeg is actively working to speed up the agency’s review of her friend’s proposal. Last fall, Hoeg gave a talk on the SSRI petition to top FDA drug officials, presenting the work as her own. Staffers who reviewed her slides found they were created by Urato.
Professional Perspective on the Petition
Outside experts say the petition relies on flimsy data, including animal studies and small trials in people. They fear a new FDA warning could cause pregnant women to stop medication unnecessarily, leading to serious health risks from untreated depression. Dr. Jennifer Payne, a University of Virginia reproductive psychiatrist, said a black box warning is a big red flag with both practitioners and patients, and what’s missing in the petition is an understanding of the risks of maternal mental illness during pregnancy.
SSRIs include most of the bestselling depression medications, including Prozac, Paxil, Zoloft, and their generic equivalents. More than 15% of U.S. women, or about 26 million people, take medication for depression, according to the latest federal figures. Professional guidelines state that antidepressants are generally safe during pregnancy and should be discontinued only after careful consultation with a doctor.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.cnn.com/2026/03/07/health/fda-antidepressant-side-effects