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FDA Starts Acetaminophen Pregnancy Warning as Trump Urges People to Avoid Tylenol

Large cohort studies report only associative findings, prompting warnings against scaring pregnant patients.

Overview

  • The FDA said on Sept. 23 it will require labels noting a "possible association" between prenatal acetaminophen use and autism.
  • President Trump told the public "Don't take Tylenol," a declaration that exceeds the agency's cautious framing.
  • A Swedish analysis of nearly 2.5 million births reported autism diagnoses of 1.42% with prenatal exposure versus 1.33% without, indicating no meaningful difference.
  • A separate Japanese cohort study involving more than 200,000 children reached similar conclusions, offering no evidence of a causal link.
  • Clinicians and commentators warn that alarmist rhetoric could deter recommended treatment for fever or pain in pregnancy and risk stigma while diverting attention from core autism research needs.