Tylenol manufacturer Kenvue is urging the Food and Drug Administration (FDA) to drop a proposed safety label change that links acetaminophen use during pregnancy to autism. The company said “expansive scientific evidence developed over many years” does not support a causal connection between the drug and developmental disorders.
In a formal response to a citizen petition filed by the Informed Consent Action Network, an anti-vaccine group tied to Health Secretary Robert F. Kennedy Jr., Kenvue argued that the request was “unsupported by scientific evidence” and would contradict the FDA’s long-standing position that acetaminophen is safe for pregnant women when used as directed.
The petition came the same day President Trump and Kennedy warned pregnant women against using Tylenol, citing an unproven link to autism. “Don’t take it. Fight like hell not to take it,” Trump said during a White House news conference.
Kenvue said it met with Kennedy and other officials earlier in September to review data showing no proven association between prenatal or postnatal acetaminophen use and conditions like autism or ADHD. FDA Commissioner Marty Makary confirmed in a letter to doctors that “a causal relationship has not been established.”
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