Kenvue, the company behind Tylenol since its 2023 spinoff from Johnson & Johnson, is preparing for a significant increase in lawsuits after federal officials under the Trump administration flagged a possible connection between acetaminophen—the active ingredient in Tylenol—and autism when taken during pregnancy. While Kenvue and some medical groups dispute the link, the Food and Drug Administration is now advising doctors to be cautious, urging pregnant women to use acetaminophen only when necessary and in the lowest effective doses, per the Wall Street Journal.
The FDA plans to update labels for products containing acetaminophen, though it notes that studies on the association are mixed, and that untreated fevers in pregnancy can carry their own risks. President Trump and Health Secretary Robert F. Kennedy Jr. have both publicly cautioned against using the drug during pregnancy, statements that could bolster plaintiffs' arguments in ongoing and future litigation.
About 500 lawsuits have already been filed since 2022, claiming prenatal Tylenol use led to autism or ADHD. So far, Kenvue has fended off these cases; a judge dismissed them in 2023 for lack of evidence. Plaintiffs are now appealing, and the recent federal warning is expected to play a central role in those appeals and in the anticipated wave of new lawsuits, which could continue for years given legal timelines for cases involving minors. Kenvue maintains that Tylenol is safe and that science doesn't support a link to autism, emphasizing the risks of untreated fever during pregnancy.
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It's not the first time Tylenol has been painted in an unflattering light. The New York Times recalls how the drug was at the center of headlines in the early '80s after the product was tampered with and seven people died, setting off a "nationwide panic." On the market side, Kenvue shares dipped after the news but partially rebounded, reflecting ongoing investor uncertainty. The FDA, meanwhile, remains cautious in its language, stating that no causal relationship has been found. USA Today has more on Kenvue, which includes such brands as Band-Aid, Neutrogena, and Benadryl.
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