Oct 20 (Reuters) - Kenvue ( KVUE ) 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 "overwhelming weight" of the evidence contradicts the
existence of any risk of the use of Tylenol and
neurodevelopmental disorders, Kenvue ( KVUE ) said, requesting the U.S.
Food and Drug Administration to deny the citizen petition.