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Kenvue Urges US FDA to Reject Request for Tylenol's Autism Warning
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By Reuters
Published 3 weeks ago on
October 20, 2025

An illustration photo shows Tylenol in Schwenksville, Pennsylvania, U.S. September 24, 2025. (Reuters/Hannah Beier)

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Kenvue has urged U.S. regulators to reject a request seeking autism warning label on its popular over-the-counter pain medication Tylenol for use during pregnancy, after President Donald Trump linked the drug to the condition.

A citizen petition filed last month requested changes to the labeling of the drug for use during pregnancy that are “unsupported by the scientific evidence and legally and procedurally improper”, the company said in its submission dated October 17.

Trump had in September warned women of the autism link, going against advice from medical societies, which cite data from numerous studies showing that acetaminophen, the active ingredient in Tylenol, plays a safe role in the well being of pregnant women.

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The “overwhelming weight” of the evidence contradicts the existence of any risk of the use of Tylenol and neurodevelopmental disorders, Kenvue said, requesting the U.S. Food and Drug Administration to deny the citizen petition.

(Reporting by Sriparna Roy in Bengaluru; Editing by Shilpi Majumdar)

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