Stronger Warnings On Tylenol And Liver Toxicity

The Food and Drug Administration (FDA) recently issued a ruling requiring drug makers to change their warning label on painkiller acetaminophen concerning the potential for liver damage and internal bleeding – but advisors think it may not go far enough.

It is easy to take more than the recommended dose of Tylenol because many over-the-counter pain relievers already contain it, increasing the potential for liver damage.  Also, many consumers take more than they should believing that more is better.  Overdosing on Tylenol can lead to severe hepatotoxicity.

The FDA calls for a limit of the maximum adult dosage to no more than 3,250 milligrams a day, but even lower for those who consume three or more alcoholic drinks per day.

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.  

Whether acetaminophen (Tylenol) or non-steroidal anti-inflammatory drugs, NSAIDs, such as aspirin, ibuprofen (Advil, Motrin), aspirin, or naproxen ( Aleve) and Excedrin – all will have to carry new warnings on the potential for stomach bleeding and the risk of liver damage.

Manufacturers must make sure that the warning label is prominently displayed on the package and the bottle. The changes must be completed by April 2010.    

Acetaminophen is one of the most popular pain and fever relievers used primarily because it does not upset the stomach the way NSAIDs can.   Hepatotoxicity can also occur when a normal dose is followed and can range from problems with liver function to acute liver failure and even death.  

A report issued by the Center for Drug Evaluation and Research in February 2008, says that in the late 1990s researched showed that Tylenol was a major cause of liver failure in the U.S. with about 40 percent of the cases related to unintentional overdosing of acetaminophen.    

By the end of June, advisors to the FDA will hold a two-day committee meeting on liver injury related to acetaminophen to consider even stronger warnings. #