Tylenol maker fights safety label change

The maker of Tylenol is pushing back against efforts to change the pregnancy warning on acetaminophen products, saying there's no evidence showing a proven link between autism and the use of the pain reliever and fever reducer.

Why it matters: It's the latest development stemming from President Trump and Health Secretary Robert F. Kennedy Jr.'s statements that there may be a connection between Tylenol use among pregnant women and autism in children.

• Kennedy on Sept. 22 announced a series of actions, including directing the FDA to begin a safety label change for Tylenol and generic equivalents.
• The FDA separately issued a notice to physicians urging them to minimize the use of acetaminophen during pregnancy for routine low-grade fevers.

What they're saying: Kenvue Brands said on Sunday that it told the FDA in a 42-page response that the labeling request is unsupported by scientific evidence and would mark a departure from the agency's long-standing position on acetaminophen during pregnancy.

• The FDA evaluated the evidence for more than a decade — and as recently as August — repeatedly concluding that the data doesn't support a causal association, the company said. The FDA also previously rejected updating the pregnancy warning.
• "Kenvue strongly believes that the existing instruction 'if pregnant or breast-feeding, ask a health professional before use' is the most conservative and appropriate warning," the company said.

Physicians and public health officials have said the risk of not treating high fevers, and the lack of safe alternatives, weigh against adding language that may discourage pregnant women from seeking appropriate treatment.

• Professional associations including the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics have found no proven link between acetaminophen use in pregnancy and neurodevelopmental disorders.