Kenvue urges US FDA to reject request for Tylenol's autism warning
Source: Reuters
October 20, 2025 4:14 PM EDT Updated 11 hours ago
Oct 20 (Reuters) - Kenvue (KVUE.N) 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 petition by Informed Consent Action Network asked the U.S. Food and Drug Administration to require Tylenol and other products containing acetaminophen have warnings about the association with the conditions, including autism and attention-deficit hyperactivity disorder. The health regulator had said last month it would add warnings to the label of Tylenol and similar products to highlight the risk.
Read more: https://www.reuters.com/business/healthcare-pharmaceuticals/kenvue-urges-us-fda-deny-request-tylenols-autism-warning-2025-10-20/
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