FDA group recommends acetaminophen liver warnings

May 27, 2009

(AP) -- A Food and Drug Administration report released Wednesday recommends stronger warnings and dose limits on drugs containing the painkiller acetaminophen, citing an increased risk of liver injury.

The recommendation covers both prescription doses and over-the-counter medication, of which Johnson & Johnson's Tylenol is the most well-known. Acetaminophen is also widely available 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 ," the working group report said.

The outside advisers will meet in June to discuss the report's findings. The recommendations include enhanced public information efforts, stronger labels warning 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 ," the report said.

The recommendations also call for limiting the maximum adult daily dose to no more than 3,250 milligrams. The current recommendation stands at 4,000 milligrams per day. Other recommendations include limiting tablet strength for immediate release formulations and limiting options in liquid formulations for children.

©2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Explore further: Discount generic drug programs grow over time

add to favorites email to friend print save as pdf

Related Stories

Acute gastric injury due to high-dose analgesics?

Dec 29, 2008

Analgesics, NSAIDs and acetaminophen, are commonly used for the relief of fever, headaches, and other minor aches and pains. The gastrointestinal side effects of NSAIDs are well documented and acetaminophen is accepted to ...

FDA toughens warnings on over-the-counter painkillers

Apr 29, 2009

The Food and Drug Administration said Tuesday that it is asking drugmakers to more prominently display safety warnings on the labels of some of the most widely used over-the-counter pain and fever remedies.

Recommended for you

Discount generic drug programs grow over time

2 hours ago

Generic discount drug programs (GDDPs, which charge nominal fees to fill prescriptions) have grown over time and their initial lower use by racial/ethnic minorities has evaporated, writes author Song Hee Hong, Ph.D., of the ...

Seniors successfully withdraw from meds

Sep 19, 2014

Elderly people have proved receptive to being de-prescribed medications, as part of a trial aimed at assessing the feasibility of withdrawal of medications among older people.

User comments : 0