Stronger painkiller warnings are sought

FDA proposal covers nonprescription drugs

December 20, 2006|By LOS ANGELES TIMES

WASHINGTON -- The government proposed yesterday stronger safety warnings for nonprescription painkillers found in most family medicine cabinets, as well as in many an office drawer and gym bag, including aspirin, Tylenol, Advil, Motrin and Aleve.

The Food and Drug Administration said it was concerned that consumers were poorly informed about serious and potentially fatal complications from misusing the medications, although the risks are well known to healthcare professionals.

"Acetaminophen is an enormous problem in the United States and overshadows prescription drug toxicity," said Dr. William M. Lee of the University of Texas Southwestern Medical Center at Dallas, a nationally recognized expert on liver failure. "This is finally doing something in response."

Acetaminophen, the active ingredient in Tylenol and its generic equivalents, is also found in many other painkillers and cold remedies. Researchers have linked overdoses of the drug to more than 56,000 emergency room visits a year and 26,000 hospitalizations, including some requiring liver transplants. The FDA estimates that 200 people a year die from acetaminophen overdoses, although others have put the figure at more than 450.

The other painkillers covered by the warning - NSAIDs, or nonsteroidal anti-inflammatory drugs - can cause bleeding in the stomach. NSAIDs include ibuprofen, which is sold as a generic and under the brand names Advil and Motrin; naproxen, the active ingredient in Aleve; and aspirin.

Both acetaminophen and NSAIDs are used for pain, fever, headaches and muscle aches. The FDA said that in any given week, 48 million adults use acetaminophen products, and 17 million take NSAIDs daily.

The FDA has been considering stronger warnings for nonprescription painkillers for more than four years. But because of the ponderous nature of the federal regulatory process, it could take another year or more before the agency's proposed wording and layout changes appear on all drug packages - unless manufacturers voluntarily embrace the changes.

The FDA's proposal - to be published in Tuesday's Federal Register - is to make the current warning information clearer and more forceful. A key element would require standard language for all medications containing the drugs. That is not the case now.

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