Tylenol maker Kenvue urges FDA to reject a request for an autism warning
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 Oct. 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 that 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.
However, in a letter to doctors, FDA Commissioner Martin Makary said, "While an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature."
"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.
Acetaminophen is the only pain reliever considered safe for pregnant women. Doctors already urge them to use the least amount of the drug for the shortest possible duration to control pain and fever during pregnancy.
Bloomberg News had reported the development earlier on Monday.