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FDA Urges Stronger Warnings On Acetaminophen Products

By Chrissie Cole

In a newly released report, the U.S. Food and Drug Administration (FDA), suggests stronger warnings on drugs that contain the painkiller acetaminophen, due to an increased risk of liver injury.

Both prescription and over-the-counter (OTC) medications are covered in the recommendation, of which Johnson & Johnson's Tylenol is most well-known.

"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.

The FDA calls for a maximum adult daily dose to be no more than 3,250 milligrams. Current recommendations are 4,000 milligrams daily.

Children's Tylenol should also be limited to one mid-strength concentration according to advisors. As it stands now, there are multiple dosage strengths available.

FDA advisers will meet in June to go over the report's findings and to consider stronger labeling.

In April, the FDA ruled OTC pain relievers -- including Advil and Tylenol -- need to carry stronger warnings.

The makers of over-the-counter (OTC) pain relievers and fever reducers must revise their labeling to include bolder warnings about potential safety risks such as liver damage and internal bleeding, associated with the use of these drugs. #

Originally posted at InjuryBoard by Chrissie Cole

Full post as published by New York City Personal Injury Lawyer on May 28, 2009 (boomark / email).