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| |  Ketoprofen May Cause Serious Stomach Problems HOUSTON, TX -- July 20, 1998 -- Recommended doses of the common over-the-counter (OTC) painkiller Orudis KT™ (ketoprofen), a member of the class of drugs known as non-steroidal anti-inflammatory drugs, may cause frequent and severe stomach and intestinal problems, according to a study published in this month’s issue of the American Journal of Gastroenterology. This is the first scientific study to report on the potential gastrointestinal (GI) effects of recommended OTC doses of ketoprofen. The randomised, double-blind, three-way crossover study compared 75mg/day of ketoprofen, with 4,000mg/day of acetaminophen, the medicine in Tylenol(TM) and a placebo. (Both levels are the maximum recommended daily doses.) Twenty-four healthy subjects between the ages of 18 and 65 received each of the three treatments for seven days of therapy. Each patient received a gastroduodenal endoscopy prior to and at the end of each treatment period to assess damage. The condition of the stomach lining and the upper portion of the small intestine was graded to assess the extent of injury. Investigators found that 50 percent of the subjects receiving ketoprofen developed severe gastric mucosal injury. Two subjects developed confirmed gastric ulcers. No significant GI effects were found in the patients taking acetaminophen, which is not an NSAID. "For some time, we've needed to assess the difference in toxicity, if any, between over-the-counter and prescription doses of ketoprofen, one of the more potent, and thus riskier, NSAIDs," said principal investigator Frank Lanza, MD, clinical professor of medicine, section of gastroenterology, Baylor College of Medicine and director of the Houston Institute for Clinical Research. "While the study does not compare OTC doses of ketoprofen to those of other NSAIDs, it clearly indicates that even recommended OTC doses of the drug have the potential to produce significant injury to the gastrointestinal tract." Non-steroidal anti-inflammatory drugs, which include aspirin and ibuprofen, are typically used to treat muscle pain and arthritis and to fight fevers. While these agents are effective in the treatment of these conditions, their toxicity, particularly their tendency to cause ulcers and GI bleeding, has been well-documented in the medical literature. In fact, gastrointestinal complications stemming from NSAID use are among the most common adverse drug reactions found in the U.S. The Centers for Disease Control and Prevention estimate that NSAID-related complications lead to 76,000 hospitalisations and 7,600 deaths each year. Lanza also noted that patients in the acetaminophen group showed no signs of injury to the stomach or duodenum, the upper portion of the small intestine. "We found virtually no difference between patients receiving acetaminophen and placebo," he said. "Our finding is consistent with previous studies showing that acetaminophen does not produce significant stomach bleeding, ulcers, or other GI distress."
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