Overview
- President Donald Trump told pregnant Americans to limit acetaminophen use unless medically necessary, and the FDA began steps to notify clinicians and pursue labeling changes noting a possible association with autism and other neurodevelopmental outcomes.
- The World Health Organization and European Medicines Agency said their guidance is unchanged, stressing paracetamol can be used in pregnancy when needed at the lowest effective dose and that existing research does not establish causation.
- The scientific record remains mixed, with a Harvard-led review reporting more frequent associations in higher-rated observational studies, while a large 2024 Swedish sibling-controlled cohort found no causal link.
- The FDA also moved to expand use of leucovorin for cerebral folate deficiency, which can overlap with some autism-associated symptoms, as experts cautioned that evidence for broader autism benefits remains preliminary.
- Medical groups and industry criticized the White House message, and GOP Sen. Bill Cassidy urged the administration to release its supporting data, as Trump’s mispronunciation of acetaminophen drew wide online attention.