WASHINGTON (WDNews) — The U.S. Food and Drug Administration announced Monday it is initiating the process to add warning labels to acetaminophen products, including Tylenol, to alert parents and physicians of potential risks when used during pregnancy.
The FDA also issued a letter to doctors nationwide citing evidence that acetaminophen use by pregnant women may be linked to an increased risk of neurological conditions such as autism and ADHD in children.
“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 Marty Makary, M.D., M.P.H. “Even with this body of evidence, the choice still belongs with parents. The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment. It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.”
Several large-scale studies, including the Nurses’ Health Study II and the Boston Birth Cohort, have found associations between prenatal acetaminophen use and later diagnoses of autism or ADHD. Researchers note that risk may be most pronounced with chronic use throughout pregnancy.
The agency emphasized that while the correlation is well-documented, a causal link has not been established, and some studies show no association. Acetaminophen remains the only over-the-counter option approved for fever during pregnancy, as aspirin and ibuprofen are known to cause harm to the fetus.
