Overview

• At a White House event, President Donald Trump claimed prenatal use of acetaminophen is associated with a higher autism risk and said the FDA would notify physicians, while also suggesting delays to newborn hepatitis B vaccination.
• The World Health Organization and the European Medicines Agency said existing studies show inconsistent associations and do not prove causation, and U.S. obstetrics groups warned against discouraging a recommended option for treating fever and pain in pregnancy.
• Hours before the announcement, the FDA posted a Federal Register notice approving a GSK leucovorin product for cerebral folate deficiency, which the White House cast as relevant to autism-related care despite experts calling current evidence preliminary.
• A large 2024 JAMA study using sibling comparisons in roughly 2.5 million Swedish children found no causal link between prenatal acetaminophen exposure and autism, ADHD or intellectual disability, though some reviews report associations without establishing cause.
• Tylenol maker Kenvue rejected any causal connection and said the medicine remains safe when used as directed, as its shares fell about 7.5% on Monday; separate U.S. lawsuits over alleged risks continue with appeals pending.