Tylenol manufacturer Kenvue Brands LLC sent a letter to the Food and Drug Administration, criticizing demands that the drug’s label be changed to reflect greater safety warnings.
“The Citizen Petition requests changes to the labeling of over-the-counter (‘OTC’) acetaminophen products for use during pregnancy that are unsupported by the scientific evidence and legally and procedurally improper—including requesting that the consumer-facing warning address a risk of acetaminophen use and neurodevelopmental disorders even though the overwhelming weight of the evidence contradicts the existence of any such risk,” the company’s letter to the FDA says.
In September, the FDA announced that it initiated the process of changing the labeling for Tylenol in light of President Trump’s announcement that acetaminophen is linked to autism development when used during pregnancy.
A letter was also sent to physicians nationwide to inform them of the accumulation of evidence “suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children.”
“Some studies have described that the risk may be most pronounced when acetaminophen is taken chronically throughout pregnancy to childbirth,” FDA Commissioner Marty Makary wrote. “These concerns may be magnified by the fact that a very young child’s liver may still be developing and thus a child’s ability to metabolize the drug may be limited.”
The letter noted that while there are “contrary studies in the scientific literature,” clinicians should still “consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers.”
