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FDA Opens Tylenol Label Review as Scientists and Global Regulators Reject Autism Claim

Leading health authorities say existing studies show associations without proving causation.

Overview

  • President Trump urged pregnant people to avoid acetaminophen and told parents not to give it to young children.
  • The FDA says a causal link is unproven and notes risks with alternatives, yet it has begun evaluating warning language about autism and ADHD.
  • A 2024 Swedish JAMA study of roughly 2.4–2.5 million births found no association in sibling‑controlled analyses between prenatal acetaminophen exposure and autism, ADHD, or intellectual disability.
  • WHO, the European Medicines Agency, the U.K.’s MHRA, and Health Canada reaffirm guidance that paracetamol remains appropriate in pregnancy when used as directed.
  • HHS announced a $50 million Autism Data Science Initiative and highlighted leucovorin for a subset of patients, while clinicians and several Republican physician‑senators warned the messaging could harm patients and urged decisions be made with doctors.