Painkillers’ health risks examined

FDA wants stronger warnings on common medications

? The government Tuesday proposed stronger safety warnings for nonprescription painkillers found in most family medicine cabinets, as well as 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 complications from misusing the medications, although the risks are well known to health-care professionals.

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

Acetaminophen, the active ingredient in Tylenol and its generic equivalents, is 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.

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.

Johnson & Johnson, the maker of Tylenol and Motrin, said Tuesday it would work with the FDA to improve safety information for consumers but stopped short of saying it would quickly adopt the proposal.

The Consumer Healthcare Products Association, a trade group representing manufacturers, said many companies have improved their safety information. “Member companies take very seriously the safe use of over-the-counter medicines,” said Linda Suydam, the association’s president.

The FDA’s proposal – to be published in next 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.

“We more or less allowed the companies to voluntarily put warnings” on their products, said Dr. Charles J. Ganley, the FDA’s director of nonprescription drugs. “The language is not the language we wanted on there.”

Although the safety concern is not new, Ganley said, the FDA is striving to improve communication to the public. The medications are safe when used as directed, he emphasized.

NSAIDs and acetaminophen are also found in prescription drugs, and that can cause different sorts of problems. Patients dependent on the codeine derivative in the painkiller Percocet, for instance, could unwittingly overdose on acetaminophen if they take Tylenol at the same time.