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FDA Reviews Tylenol Label as WHO Rejects Claims of Prenatal Link to Autism

Global health authorities say evidence does not show a causal link from prenatal acetaminophen to autism.

Overview

  • The FDA said on Sept. 23 it would require new warning language noting a possible association between prenatal acetaminophen use and neurodevelopmental outcomes.
  • President Trump urged people not to use Tylenol, including during pregnancy and in children, prompting confusion and heightened scrutiny of the science.
  • WHO stated there is no conclusive evidence that acetaminophen in pregnancy causes autism, and ACOG and the AAP reaffirmed guidance for judicious, clinician‑guided use.
  • Recent large observational studies, including Swedish and Japanese cohorts, reported negligible or no meaningful differences in autism diagnoses linked to prenatal exposure.
  • Clinicians and commentators warn that alarmist claims could deter needed treatment or push parents toward aspirin for fevers, reviving concerns about Reye syndrome.