The U.S. FDA has initiated a label change for acetaminophen (Tylenol and similar products) to reflect "evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children."
The agency also issued a related letter alerting physicians nationwide.
President Trump shared these claims during a White House briefing Monday night, urging pregnant women to avoid acetaminophen.
According to the agency, multiple large-scale cohort studies, including the Nurses’ Health Study II and the Boston Birth Cohort, find this association. Some studies have described that the risk may be most pronounced when acetaminophen is taken chronically throughout pregnancy.
Importantly, the agency also stated that, “while an association between acetaminophen and neurological conditions has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature.”
Medical experts fired back, including the American College of Obstetricians and Gynecologists. “Suggestions that acetaminophen use in pregnancy causes autism are not only highly concerning to clinicians but also irresponsible when considering the harmful and confusing message they send to pregnant patients, including those who may need to rely on this beneficial medicine during pregnancy,” said Steven J. Fleischman, ACOG president.