WASHINGTON – The U.S. Food and Drug Administration (FDA) is moving to change the product label for acetaminophen, the active ingredient in Tylenol and other over-the-counter medications. The change is being made to reflect a potential link between the use of the drug by pregnant women and an increased risk of neurological conditions like autism and ADHD in their children. The agency has also issued an advisory letter to physicians nationwide.
“The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,” said FDA Commissioner Dr. Marty Makary. While a causal relationship has not been definitively established, multiple large-scale studies, including the Nurses’ Health Study II and the Boston Birth Cohort, have shown a correlation, particularly with chronic use throughout pregnancy.
The FDA noted that while the new label addresses these concerns, the final decision on using the drug during pregnancy still rests with parents and their healthcare providers. Makary suggested that the “precautionary principle” may lead many to avoid it for low-grade fevers, but he stressed that it remains a reasonable option in specific scenarios.
The agency also highlighted that high fevers in pregnant women can be a risk to their children. Additionally, other common pain relievers like aspirin and ibuprofen are not recommended for pregnant women due to their documented adverse effects on the fetus.
