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White House Flags Prenatal Tylenol Risk as FDA Prepares Guidance and Label Review

Officials caution that the evidence is observational, not proof of a causal link to autism.

Overview

  • President Trump said the FDA will notify clinicians about a possible association between prenatal acetaminophen use and neurodevelopmental disorders and will evaluate warning language.
  • An FDA letter cited by Virginia health officials says studies describe associations but not causation and calls acetaminophen the safest over-the-counter option for pain and fever in pregnancy.
  • ACOG and the WHO urged pregnant patients to follow clinician advice, and physicians including Dr. Manisha Juthani and Yale’s Dr. Hugh Taylor emphasized treating fever and noted acetaminophen remains the preferred choice.
  • Research remains mixed, with a 46-study review reporting many associations and a large Swedish sibling-controlled cohort finding the associations disappear within families, underscoring confounding concerns.
  • Reactions span appreciative and skeptical parents, sharp criticism from Barack Obama, a denial of causation from Tylenol maker Kenvue, and social-media protests featuring people publicly taking the drug.