After popular pain med Tylenol came under fire from officials in the Trump administration for an alleged link to autism if used during pregnancy, the product's manufacturer is fighting back at a proposed FDA label change by laying out evidence in support of the product's safety.
The 42-page submission (PDF) from Kenvue was filed on Oct. 17 as a comment to an FDA Citizen Petition that the Informed Consent Action Network (ICAN) submitted to the agency on Sept. 23. The petition calls on the FDA to revise its label for all over-the-counter (OTC) drugs containing acetaminophen, Tylenol’s active ingredient, to include warnings against their use during pregnancy.
ICAN's 12-page petition requests that the agency change the drug's label to note that “studies show that frequent use of this product during pregnancy may increase your child’s risk of neurodevelopmental disorders” and that pregnant women should, if “strictly necessary,” use the “lowest effective dose for the shortest possible time” to treat pain or fever.
Kenvue has repeatedly backed the safety of its product and now has taken the chance to directly respond to ICAN’s arguments. ICAN is a litigious activist organization that’s dedicated to the “eradication of man-made disease," according to its website.
Along with sharing the findings of 50 years' worth of research on the med, Kenvue pointed to the FDA’s own long-held position on the use of acetaminophen during pregnancy, suggesting that a label change would mark an “unexplained departure” from the agency’s stance.
As recently as August, the FDA’s acetaminophen-specific web page listed that it had “not found clear evidence” that appropriate use of the drug causes adverse developmental outcomes.
Kenvue also reminded the FDA of its own repeated cautions about the “potential dangers of overwarning,” explaining that the agency has “consistently emphasized” that OTC warnings must be “clear, concise, and evidence-based” so as to not confuse consumers or weaken key safety messages.
“Because the science does not support a change to the warning language and the proposed labeling changes could be harmful to pregnant women and result in adverse pregnancy outcomes, Kenvue strongly opposes the changes and believes that the existing instruction to speak to a health professional before use in pregnancy is the most conservative and appropriate labeling,” the company wrote in its response.
As Kenvue advises, any agency action other than denying the petition would be “arbitrary and capricious” and could violate federal law that dictates the administrative process of label changes.
Tylenol has long been marketed by Johnson & Johnson since its first approval many decades ago, but the franchise recently switched hands to the company’s consumer healthcare spinout Kenvue. The drug is “one of the most studied medicines in history,” according to Kenvue, with more than 150 studies supporting its safety and efficacy profile.
White House autism push
U.S. health officials began floating a potential link between autism and Tylenol use in September, months into Department of Health and Human Services Secretary Robert F. Kennedy Jr.’s investigation into the nation's “autism epidemic.”
At a White House press conference, President Donald Trump advised that pregnant women should “tough it out” and not take Tylenol, citing a “very increased” risk of autism. That day, FDA Commissioner Marty Makary, M.D., inked a notice to physicians urging them to “consider minimizing” the use of acetaminophen during pregnancy to treat “routine low-grade fevers.”
However, Makary’s letter clarified that a causal relationship between acetaminophen use during pregnancy and autism has not been established. Still, the agency announced on Sept. 22 that it had “initiated the process” for a label change.