Overview

• President Trump announced that the FDA will notify physicians that using acetaminophen (Tylenol) during pregnancy may be associated with increased autism risk and recommended limiting use in early pregnancy to medically necessary cases such as high fever.
• The administration spotlighted leucovorin, a folate derivative, for evaluation as a potential autism therapy, with officials acknowledging that evidence remains preliminary.
• Kenvue, maker of Tylenol, rejected a causal link and cited decades of research supporting safety, as its shares fell about 7.5% on Monday following the announcement.
• Scientists and professional societies, including ACOG, pointed to a 2024 Swedish analysis of roughly 2.4–2.5 million births that found no causal association and warned that deterring appropriate treatment of fever or pain in pregnancy could cause harm.
• Hundreds of U.S. lawsuits tying Tylenol to autism were previously dismissed for insufficient scientific proof, with appeals still pending.