US EditionTylenol Maker: Possible FDA Label Change ‘Unsupported by Scientific Evidence’
Kenvue argues the petition lacks scientific support and warns that a label change could cause confusion and harm its largest product amid ongoing lawsuits.
- On Oct. 17, Kenvue told the U.S. Food and Drug Administration it opposes a pregnancy warning request on Tylenol, filing a detailed response against the proposed label changes.
- Last month, the Informed Consent Action Network filed a petition asking the FDA to require warnings linking acetaminophen products to autism and ADHD.
- Citing FDA evaluations, the company said the "overwhelming weight of the evidence" and reviews over more than a decade, including August, do not support acetaminophen’s neurodevelopmental risks.
- The dispute adds to Kenvue's risks, as last week shares sank $1 billion amid unrelated UK talc litigation, and it warns of lawsuits over the autism warning request.
- Kenvue argued administratively that its 42-page submission responds to the Informed Consent Action Network petition and that FDA must reply within 180 days, calling the petition by plaintiff-side lawyers "arbitrary and capricious" under the Administrative Procedure Act.
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Tylenol’s maker pushes back against possible label change linking pain reliever’s use in pregnancy to autism - WSVN 7News | Miami News, Weather, Sports
(CNN) — Kenvue, the American company that makes Tylenol, says the US Food and Drug Administration should not make proposed changes to the product’s safety label to reflect research about a possible connection between its use in pregnancy and diagnoses of autism or ADHD in children. Kenvue says that acetaminophen, the generic name for the painkiller and fever reducer also known as paracetamol, is “one of the most studied medicines in history” and…
Tylenol maker: possible FDA label change ‘unsupported by scientific evidence’
Tylenol maker Kenvue is calling on the Food and Drug Administration to back off a proposed safety label change to acetaminophen after the Trump administration linked its use during pregnancy to autism. In response to a citizen petition filed last month, the company said the “expansive scientific evidence developed over many years” does not support a causal link between acetaminophen use in pregnancy and developmental disorders. …
Tylenol Manufacturer Resists Proposed Label Changes
Kenvue Brands LLC, the manufacturer of Tylenol, sent a letter to the Food and Drug Administration on Oct. 17, pushing back against demands to modify the medication’s label to show more safety warnings. On Sept. 22, federal officials said that Tylenol use during pregnancy is likely associated with autism and that pregnant women should not take the drug unless they have severe fevers. The FDA sent a letter to doctors on Sept. 22, notifying them th…
Kenvue, the US company that makes Tylenol, says the US Food and Drug Administration should not make proposed changes to the product's safety label to reflect the investigation into a possible connection between…
By Jen Christensen, CNN Kenvue, the US company that makes Tylenol, says the US Food and Drug Administration should not make proposed changes to the product’s safety label to reflect research into a possible connection between its use during pregnancy and diagnoses of autism or ADHD in children. Kenvue says acetaminophen, the generic name for the pain reliever and fever reducer also known as paracetamol, is “one of the most studied drugs in histo…
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