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White House Links Prenatal Tylenol Use to Autism Risk, Plans FDA Warning and Label Review

Experts warn the evidence does not show causation, with untreated fever in pregnancy posing its own risks.

Overview

  • President Trump and HHS said acetaminophen use during pregnancy can be associated with increased autism risk and urged pregnant patients to limit use unless medically necessary.
  • Trump said the FDA will notify clinicians and start a Tylenol safety label change; agency communications reported by outlets note a causal relationship has not been established.
  • The administration promoted leucovorin as a potential therapy for some autism symptoms, with Trump saying the FDA is updating labeling, and NIH announced $50 million for an Autism Data Science Initiative.
  • Kenvue and major medical organizations, including ACOG, rejected claims of causation and cautioned that alarming messages could deter treatment of fever and pain in pregnancy.
  • Recent reviews report associations based on observational data, while a large 2024 Swedish sibling study found no causal link, underscoring ongoing scientific uncertainty as federal research proceeds.