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| |  Patients Still Unaware Of Harmful Effects Of Some Pain Drugs NEW YORK -- July 17, 1997 -- People need to become aware that ulcers and other medical problems can be the result of continually taking widely prescribed and over-the-counter pain medications, according to a leading gastroenterologist. "It's a public health problem," says Michael B. Kimmey, M.D., Director of Gastrointestinal Endoscopy, University of Washington Medical Center, Professor of Medicine and Assistant Chief for Clinical Affairs, Division of Gastroenterology, University of Washington, Seattle. Dr. Kimmey spoke today at an American Medical Association (AMA) media briefing in New York on the complications of nonsteroidal anti-inflammatory drugs (NSAIDs). Aspirin or other NSAIDs can be an ingredient in many over-the-counter drugs, so some people may not even realize they're taking them. Dr. Kimmey says he would like to see pharmaceutical companies and the government both make an effort to help consumers become aware that they need to be cautious about these drugs. "I think we need to have some responsible advertising. And we probably need to have that enforced by the Food and Drug Administration (FDA)," he says. Data from the Arthritis, Rheumatism and Aging Medical Information System indicate that approximately 76,000 hospitalizations occur each year from NSAID-induced gastrointestinal (GI) complications. Each hospitalization costs an average of $10,000. Aspirin is the most familiar NSAID. NSAIDs also include ibuprofen, naproxen sodium and ketoprofen -- each available in both prescription and over-the-counter form -- as well as a number of drugs available by prescription only. They are commonly used by millions of Americans to ease pain -- and in the case of aspirin, may also be prescribed for some cardiac patients. A key problem, says Dr. Kimmey, is that many over-the-counter NSAIDs are taken by people who don't have a good reason to take them. "Most of these drugs are not taken because doctors advise people to take them ... People see advertisements and they go and get them without talking to a doctor." By doing so, Dr. Kimmey says people may be "placing themselves at risk for a catastrophic problem". The U.S. Food and Drug Administration (FDA) is currently reviewing revised label applications from pharmaceutical companies which manufacture NSAIDs. The government aganeyc sent letters to NSAID manufacturers late last year after its Arthritis Advisory Committee unanimously recommended that all NSAID labeling be updated to include warnings regarding risk factors for severe GI complications. Proposed label warnings include information that GI complications occur in approximately one-percent of patients treated with NSAIDs for 3-6 months, and occur in 2-4 percent of patients treated for one year. Complications of NSAID Use Dr. Kimmey says people who take NSAIDs for several months may suffer any of three types of GI side effects: --Dyspepsia - Upper abdominal discomfort is common among people using these drugs. But most people who experience stomach aches do not develop ulcers. --Mucosal lesions - These lesions are usually detected only through endoscopy, in which a lighted tube is passed into the stomach. Most people who develop these lesions do not have any symptoms. --Ulcers - These are deeper sores or holes in the lining of the stomach or duodenum, and they may be accompanied by complications that include bleeding and perforation. Dr. Kimmey points out that 50 to 80 percent of people who show up inhospitals suffering from GI bleeding are taking NSAIDs. "Every time they come in with bleeding, they have a 10 percent chance of dying. I don't think people realize that until it may be too late." Minimizing the Risks Dr. Kimmey has these suggestions for patients who want to cut down on their risk of developing complications from NSAID use: --Try an alternative medication. There are other drugs for pain without GI toxicity -- including acetaminophen. --Try using an anti-inflammatory drug that is not as potent -- but also, not as toxic. --Try a lower dose of the drug. He adds that for patients on prescription drugs, some prescriptions are safer than others. And for people at highest risk -- those with previous ulcers or ulcer complications, and patients taking steroids or blood-thinning drugs -- a prophylactic drug can be given along with the NSAID to try to prevent ulcers from developing.
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