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Kenvue urges US FDA to reject request for Tylenol's autism warning
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Kenvue urges US FDA to reject request for Tylenol's autism warning
Oct 20, 2025 10:12 AM

Oct 20 (Reuters) - Kenvue ( KVUE ) 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.

The "overwhelming weight" of the evidence contradicts the

existence of any risk of the use of Tylenol and

neurodevelopmental disorders, Kenvue ( KVUE ) said, requesting the U.S.

Food and Drug Administration to deny the citizen petition.

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