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

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