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Hello, This article is from the Grand Rapids Press on Tuesday, January 9, 2007. PAIN PILLS MAY CARRY WARNINGS: Take Lowest Dosage For Shortest Possible Time The Washington Post. WASHINGTON -- A recent Food and Drug Administration proposal to add stronger warning labels to several popular types of over-the-counter pain-killers, noting they pose a risk of liver and stomach damage, should not scare most consumers into avoiding the products entirely, experts say. But the news should remind patients to take the lowest dose needed for the shortest possible time and to be aware of the ingredients contained in all of their medications, particularly when taking more than one medicine. Under the FDA's proposal, warnings would be added to the labels of all over-the-counter medicines containing acetaminophen and nonsteroidal anti-inflammatory

drugs (NSAIDs), including aspirin, naproxen and ibuprofen, which are use to treat headaches, pain, fever, menstrual cramps, and muscle aches. Affected products include such popular brands as Tylenol, Aleve, Motrin and Advil. The warnings would "include important safety information regarding the potential for stomach bleeding and liver damage and when to consult a doctor," the FDA reported in a written statement. "In general, I think occasional use is safe," except in high-risk patients, said Jack Di Palma, immediate plast president of the American College of Gastroenterology. High-risk patients include people older than 60, those taking the medications for longer than directed, patients taking blood thinners or more than one medication containing an NSAID and patients who have ulcers or stomach bleeding. Gastroenterologists have been discouraging the use of NSAIDs for

patients in these groups for years, he said. When such patients disregard this advice, Di Palma said, "we've suggested trying to do things to limit injury," such as taking proton pump inhibitors (stomach-protecting medications) to protect the gastrointestinal tract. For most other patients, he says, risks are minimal. Doctors have known for years that NSAIDs can cause kidney damage and gastrointestinal bleeding in some patients, even when taken at recommended dosages. They know acetaminophen can cause severe liver damage when taken at higher than recommended doses or in combination with three or more alcoholic drinks per day. It's expected to be a year before stronger labels appear on OTC (over-the-counter) medication bottles.

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