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FDA reviews SSRI pregnancy warning petition amid conflict-of-interest concerns.
The FDA is reviewing a citizen petition calling for stronger pregnancy warnings on SSRIs, citing potential risks like miscarriage and developmental issues, amid controversy over top regulator Dr. Tracy Beth Hoeg’s close ties to the petition’s author, Dr. Adam Urato.
Hoeg, who has no prior government experience and is known for skepticism of public health measures, is reportedly seeking to appoint Urato as a senior adviser while advancing the petition, raising conflict-of-interest concerns.
Critics warn the warnings could deter pregnant women from taking necessary medication, risking harm from untreated depression.
The FDA is legally required to respond in writing, and the Department of Health and Human Services confirmed the agency will address the petition directly.
A correction clarified that nine, not ten, experts at a July meeting were critics, and Urato was sought as a senior adviser, not a full-time employee.
La FDA revisa la petición de advertencia de embarazo de SSRI en medio de preocupaciones de conflicto de intereses.