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Tylenol maker urges FDA to reject warning about autism
Los Angeles Times
|October 21, 2025
Kenvue urged U.S. regulators to deny a request warning against Tylenol’s use during pregnancy, laying out the most detailed defense of its biggest product after Trump administration officials tied its use to autism.
A citizen petition filed last month asked for changes to the label “that are unsupported by the scientific evidence and legally and procedurally improper,” the company said in an Oct. 17 submission to the U.S. Food and Drug Administration. The “overwhelming weight of the evidence” contradicts any claim that the nonprescription medicine used to treat pain and reduce fevers is a risk for neurodevelopmental disorders, the company said.
The 42-page submission came in response to the Informed Consent Action Network's citizen petition, a formal request to the FDA to take action that must be responded to within 180 days.
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