J&J Under Scrutiny as FDA Reviews Tylenol's Autism, ADHD Link
Federal agency to update acetaminophen labeling, citing potential risks for use during pregnancy, creating uncertainty for the pharma giant.
Johnson & Johnson (JNJ) faces fresh headwinds as the U.S. Food and Drug Administration (FDA) initiates a process to update labeling for acetaminophen, the active ingredient in its blockbuster product Tylenol. The review stems from concerns about a potential link between the drug's use during pregnancy and an increased risk of autism and ADHD in children, casting a shadow of legal and reputational risk over the pharmaceutical giant.
The FDA's move, described as a "precautionary principle" by officials, aims to inform consumers and medical professionals about the ongoing debate, even as a definitive causal link remains unproven. This action comes despite a federal judge dismissing hundreds of lawsuits in August 2024 that alleged Tylenol use during pregnancy caused neurological disorders, a ruling that is currently under appeal by the plaintiffs. The is now a focal point in these ongoing legal battles, adding a new layer of complexity to the litigation landscape for Johnson & Johnson.
Major medical bodies, including the American College of Obstetricians and Gynecologists (ACOG), have expressed concerns that the FDA's action could cause undue alarm. They emphasize that high-quality studies have not proven a causal link and that untreated pain or fever during pregnancy can pose its own set of risks. The , with some observational studies suggesting a correlation, while other large-scale studies, including a 2024 nationwide cohort study in Sweden, found no such link when accounting for familial factors.
For Johnson & Johnson, the financial and reputational stakes are substantial. Tylenol is a cornerstone of its consumer health division, and any change in labeling that suggests a risk, however small or unproven, could impact sales and consumer trust. The move also opens the door to further litigation, regardless of the scientific consensus. Investors will be closely watching the outcome of the ongoing lawsuit appeals and the final language of the FDA's updated label. The that research does not show a causal link between acetaminophen use in children or during pregnancy and autism. The continue to be a significant legal challenge for the company.