Acetaminophen Liver Warnings Recommended by FDA group

Jessica Smagacz
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Posted by Jessica SmagaczMay 28, 2009 11:55 PM

AP reported that an FDA group released a report this past Wednesday recommending stronger warnings and dose limits on drugs that have the painkiller acetaminophen because of an increased risk of liver injury.

Acetaminophen is available as a generic over-the-counter drug and is also available in prescription drugs. The most well-known over-the-counter drug acetaminophen is found in Johnson & Johnson’s Tylenol.

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.”

The FDA group recommended better public information efforts, stronger labels warning of these liver side effects, and does limitations.

The report also said, “"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."

Meetings and discussions on these recommendations will be occurring soon.

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