Acetaminophen in pregnancy does not raise autism risk, study finds

A large systematic review and meta-analysis published Jan. 16 found no link between maternal acetaminophen use during pregnancy and autism, ADHD or intellectual disability; major medical organizations have pushed back against earlier claims suggesting a causal connection.

A large systematic review and meta-analysis published Jan. 16 in The Lancet Obstetrics, Gynecology, & Women's Health found no association between maternal acetaminophen use during pregnancy and autism in children. The finding contrasts with statements made last fall by President Trump and Health and Human Services Secretary Robert F. Kennedy Jr., and with an FDA letter that noted an "association" and said it would initiate a label change. Major medical groups and many experts publicly rejected those earlier claims and expressed concern about discouraging acetaminophen use in pregnancy. They also highlighted that acetaminophen is one of the few commonly used options to manage pain and fever during pregnancy and that untreated fever or severe pain carries health risks for mother and baby. Key facts: - The new research is a systematic review of 43 prior studies and a meta-analysis of 17 studies; the authors concluded that acetaminophen use in pregnancy does not increase the risk of autism, ADHD or intellectual disability. - The Food and Drug Administration sent a letter to physicians saying it would initiate a label change and cited an "association," while also noting that a causal relationship has not been established. - The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine issued statements saying research has not shown that acetaminophen causes neurodevelopmental disorders and that they will not change their recommendations. - Experts and some recent studies have suggested inconsistent results; some researchers say associations seen in past work may reflect underlying illness, pain or fever rather than the medication itself. - Clinicians warned that acetaminophen is among the limited treatment options for pain and fever in pregnancy and that leaving fever or serious pain untreated carries risks for both pregnant people and their fetuses. Summary: The study reinforces positions from major medical organizations that existing research has not established a causal link between acetaminophen use in pregnancy and autism or other neurodevelopmental disorders. The FDA has announced plans to pursue a label change, and further actions or finalized guidance are undetermined at this time.