Kenvue, the maker of Tylenol, defended the safety of the pain reliever as federal health officials prepare to update acetaminophen warning labels following claims that the drug may increase the risk of autism and ADHD when used during pregnancy.
During a Sept. 22 press conference, President Donald Trump said Tylenol (acetaminophen) use in pregnancy is “not good” and called for pregnant individuals to limit its use unless medically necessary. HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Mehmet Oz, MD, said the FDA would update safety labels based on studies suggesting a potential link to developmental outcomes.
The move follows a CDC report estimating that 1 in 31 U.S. children are diagnosed with autism by age 8. A 2024 Swedish study found no association between acetaminophen use and autism or ADHD. The Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists said the drug remains appropriate for use during pregnancy.
Kenvue has not issued a public statement specific to the FDA’s label change. However, the company submitted an Oct. 18 petition response to the agency defending the safety of its over-the-counter products.
