FDA and Kenvue Say No Autism Link to Tylenol Use During Pregnancy

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The maker of Tylenol is urging U.S. health regulators not to add an autism warning label to it and other pain-relievers containing acetaminophen, calling the request “unsupported by the scientific evidence and legally and procedurally improper.”

Kenvue’s response, dated Oct. 17, came after a citizen petition sought new pregnancy warnings for acetaminophen. 

The petition, filed by the Informed Consent Action Network, asked the U.S. Food and Drug Administration (FDA) to note a possible link between prenatal exposure and autism or attention-deficit/hyperactivity disorder (ADHD).

The petition piggybacked on recent remarks by President Donald Trump, who said Tylenol might cause autism — a claim many health experts say is not supported by science.

“For over a decade — and as recently as August — FDA has fully evaluated the emerging scientific evidence and repeatedly concluded that the data do not support a causal association between acetaminophen use in pregnancy and neurodevelopmental disorders such as autism,” Kenvue said.

In a letter to doctors, FDA Commissioner Dr. Martin Makary said that while some studies describe an association, “a causal relationship has not been established and there are contrary studies in the scientific literature,” NBC News reported.

Experts say acetaminophen remains the only pain reliever considered safe during pregnancy.

More information

The Mayo Clinic has more on acetaminophen.

SOURCE: NBC News, Oct. 21, 2025

Source: HealthDay

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