Key points
- The petition seeks explicit warnings about autism and ADHD related to acetaminophen use during pregnancy.
- Kenvue argues that the petition is not supported by conclusive scientific evidence and that FDA reviews have not established a causal link.
- FDA officials have indicated ongoing consideration of labeling updates, but the agency has stressed that evidence to date does not demonstrate causality.
- Acetaminophen remains the preferred analgesic during pregnancy when used according to clinical guidance.
Kenvue, the manufacturer of Tylenol, has urged U.S. regulators to reject a citizen petition seeking autism warnings on Tylenol and other acetaminophen-containing products used during pregnancy. The company argued that the petition’s labeling changes are unsupported by scientific evidence and procedurally improper, according to a submission dated October 17.
The petition, filed last month by Informed Consent Action Network, called for warnings on acetaminophen-containing products about potential associations with autism and attention-deficit/hyperactivity disorder (ADHD).
The petition followed remarks by President Trump in September linking the drug to autism, a claim that medical societies have cautioned against, noting extensive research showing acetaminophen can be used safely during pregnancy when taken as directed.
FDA labeling actions had previously indicated that warnings about potential risks would be added to Tylenol and similar products. In its response, Kenvue stated that the FDA’s assessments have not established a causal relationship between prenatal acetaminophen exposure and neurodevelopmental disorders, including autism.
The company cited a letter from FDA Commissioner Martin Makary to physicians, which acknowledged that while some studies describe an association, a causal link has not been proven and findings in the literature remain inconsistent.
Makary emphasized that many studies report no causal relationship, and that the FDA has, over more than a decade, evaluated the evolving evidence and repeatedly concluded that current data do not support a causal link between acetaminophen use in pregnancy and autism or other neurodevelopmental disorders. Kenvue echoed this position, underscoring that acetaminophen remains the only over-the-counter analgesic generally considered safe for pregnant women when used appropriately.
Clinical guidance continues to advise pregnant patients to use the lowest effective dose for the shortest possible duration to manage pain and fever. Healthcare providers typically emphasize prudent use of acetaminophen during pregnancy, balancing symptom relief with potential risks and individual medical considerations.
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