Overview

• An FDA letter to clinicians says prenatal acetaminophen use may be associated with neurological outcomes but emphasizes causation is not established and confirms it remains the safest over‑the‑counter option in pregnancy.
• CMS administrator Dr. Mehmet Oz clarified that federal guidance does not tell pregnant women to “never” take Tylenol, advising use for high fevers or significant symptoms based on a doctor’s recommendation.
• Kenvue, Tylenol’s parent, rejected a causal link to autism and said an old 2017 brand tweet resurfaced by the White House and HHS is being taken out of context.
• Clinicians report immediate fallout from the president’s remarks, including patient anxiety about past Tylenol use and new hesitancy around routine childhood vaccinations.
• Evidence remains mixed, with a 2024 Swedish study finding no causal link and a recent review noting associations in observational data, as HHS promotes messages to use the lowest effective dose for the shortest duration in pregnancy.