May 28, 2009

Acetaminophen A Bigger Risk Than Previously Thought

The Food and Drug Administration, citing an increased risk of liver injury, released stronger warnings and dose limits on drugs containing the painkiller acetaminophen on Wednesday.

The recommendation is for the prescription doses and over-the-counter medication.  Acetaminophen, more commonly known as Tylenol, is available widely as a generic over-the-counter drug.

"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 working group report said.

There will be a meeting in June with the outside advisers to discuss the report's findings.  Some recommendations include enhanced public information efforts, stronger label warnings of liver side effects, and dose limitations.

"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," the report said.

A call for a recommendation to limit the maximum adult daily dose to no more than 3,250 milligrams is in place.  Currently the recommendation is set at a maximum of 4,000 milligrams a day.  Other recommendations include limits of tablet strength for immediate release formulations and limiting options in liquid formulations for children.


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