US EditionTylenol Maker Opposes FDA Petition for Autism-Related Pregnancy Warning Labels
Kenvue says scientific evidence does not support a causal link between acetaminophen use in pregnancy and autism, opposing a warning label petition filed by an anti-vaccine group.
- Kenvue urged U.S. Food and Drug Administration regulators to reject the citizen petition seeking an autism warning on Tylenol, calling the proposed label changes `arbitrary, capricious and contrary to law`.
- Last month, the Informed Consent Action Network petitioned the FDA to require warnings linking acetaminophen to autism and ADHD, coinciding with President Donald Trump's related press conference.
- For over a decade, the FDA has reviewed evidence and repeatedly concluded data do not support a causal link between acetaminophen in pregnancy and neurodevelopmental disorders, while doctors urge minimal use and Kenvue says acetaminophen is extensively studied.
- The FDA said last month it would add warnings to Tylenol and similar products, and Bloomberg News reported the development earlier on Monday.
- Kenvue told the FDA its Oct. 17 submission called the petition scientifically and legally unsupported, while related coverage noted the scientist cited received $150,000 from plaintiffs suing the maker.
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FDA and Kenvue Say No Autism Link to Tylenol Use During Pregnancy
Key Takeaways
Tylenol maker urges FDA to reject request for an autism warning
Kenvue has urged U.S. regulators to reject a request seeking autism warning label on its popular over-the-counter pain medication Tylenol for use during pregnancy, after President Donald Trump linked the drug to the condition
Tylenol maker opposes FDA petition for autism-related pregnancy warning labels
The makers of Tylenol are pushing back against proposed changes to the medication's safety label following a petition from an anti-vaccine advocacy group.The U.S. Food and Drug Administration received a petition from the Informed Consent Action Network, an anti-vaccine nonprofit, requesting a more detailed warning that includes language stating use during pregnancy increases the risk of neurodevelopmental disorders.RELATED STORY | Scientist behi…
Kenvue pushes back on possible Tylenol label change
Following a White House press conference on Sept. 22, during which Donald Trump alleged a link between acetaminophen use during pregnancy and autism, the Informed Consent Network (ICAN) filed a petition with the FDA to add a warning to all drugs that contain acetaminophen. ICAN is a nonprofit organization that aims to provide “every person… The post Kenvue pushes back on possible Tylenol label change appeared first on Drug Discovery and Developm…
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