Kenvue, Tylenol manufacturer, has asked US regulators to reject a request for an autism warning label on Tylenol when used during pregnancy, calling the move unsupported by science.
The request comes from a citizen petition filed by the Informed Consent Action Network in September, urging the FDA to add warnings regarding association between Acetaminophen.
Acetaminophen is an active ingredient in Tylenol, which is an anti-pyretic, and neurodevelopmental disorders, including autism.
The controversy gained significant traction after US President Donald Trump publicly tied Tylenol use during pregnancy with autism, contrary to the medical guidelines.
In an October 17 letter, Kenvue stated that the proposed label changes do not have any science-backed evidence. The FDA addressed it is reviewing the issue and has stated it would update labels to highlight potential risks.
However, FDA Commissioner Martin Makary clarified that while some studies reveal a potential link, a causal association has not been proven, and other research contradicts the claim.
Kenvue stated, “For over a decade, the FDA has repeatedly concluded that the data do not support a causal link between acetaminophen use during pregnancy and autism.”
As mentioned earlier, Acetaminophen is an anti-pyretic, which is used to treat fever and considered pain reliever safe for use in pregnancy.
