FDA Wants New Safety Warnings for Acetaminophen

"Extensive Evidence of Hepatotoxicity" Prompts FDA Recommendation

According to the Associated Press (AP), the Food and Drug Administration (FDA) has released a report today recommending stronger safety warnings and dose limits be placed on acetaminophen, a popular pain killer available both over-the-counter, by prescription and in generic formulations. The reason is risk of liver injury.

The working group report said "There is extensive evidence that hepatotoxicity (liver toxicity) caused by acetaminophen use may result from lack of consumer awareness that acetaminophen can cause severe liver injury." And, "Consumers may not be aware that acetaminophen is present in many over-the-counter combination products, so they may unknowingly exceed the recommended acetaminophen dose if they take more than one acetaminophen product without knowing that both contain acetaminophen." One of the most well known acetaminophen-containing products is Johnson & Johnson's Tylenol.

The committee of advisors is set to meet in June to evaluate the report and consider the FDA recommendations, which include limiting the options available as paediatric liquid formulations, limiting the maximum daily dose for adults to 3,250 milligrams, and limiting tablet strength for immediate release preparations.

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Last updated on Mar-28-11