The U.S. Food and Drug Administration (FDA) has initiated the process for a label change on products containing acetaminophen, including Kenvue's Tylenol. The proposed change would state that the ingredient is associated with a higher risk of autism in children when taken by pregnant women.
This regulatory action follows warnings from President Donald Trump regarding an unproven link between Tylenol use during pregnancy and autism. If the FDA successfully mandates this label change, consumers suing Kenvue for their child’s autism will likely be able to use the new warnings as evidence in court, according to plaintiffs’ lawyers.
The FDA's move risks reinvigorating a barrage of litigation over the issue, which Kenvue has sought to put behind it. This development poses a mounting crisis for the Tylenol maker, potentially impacting its financial condition and brand reputation significantly.
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