|Volume 6 Issue 52 Published - 14:00 UTC 08:00 EST 21-Feb-2004 Next Update - 14:00 UTC 08:00 EST 22-Feb-2004||Editor: Susan K. Boyer, RN
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FDA launches educational campaign about risk of over-the-counter pain relievers and the risk of ulcer complications
The United States Food and Drug Administration (FDA) has launched the REDUCE (Risk Education to Decrease Ulcer Complications and their Effects from NSAIDs) Campaign to promote widespread awareness of the side effects of commonly used NSAIDs (nonsteroidal anti-inflammatory drugs). These medications, which include ibuprofen and aspirin, have been linked to potentially fatal disorders, such as ulcers and severe stomach bleeding.
UAB Director of the Division of Gastroenterology and Hepatology Mel Wilcox, MD, is national chair of the REDUCE Campaign, which is sponsored by the American Gastroenterological Association (AGA).
"Startling statistics show these medications lead to more than 100,000 hospitalizations and 6,000 deaths each year in the U.S. — more deaths than from AIDS and more than four times as many deaths as caused by cervical cancer," Dr. Wilcox says.
"Side effects resulting from NSAIDs are a serious, highly unrecognized health risk," continues Dr. Wilcox, who also is AGA secretary and professor of medicine at UAB. "NSAID overuse is one of the leading causes of stomach problems, including bleeding ulcers, and these potentially deadly problems can begin within weeks of taking medications and occur without warning."
More than 30 million Americans take NSAIDs every day for a swift and easy solution to discomfort caused by everything from headaches to arthritis. Even though they can be effective, individuals are largely unaware that they may be at risk for developing serious side effects — and 4 out of 5 people do not experience any warning symptoms. "There is no medical test to determine the level of individual risk, although certain factors, such as age 60 and older, incidence of previous ulcers, use of steroid medications or blood thinners, and misuse of NSAIDs, increase the potential for side effects," Dr. Wilcox cautions.
Indeed, data presented at the 2002 FDA Non-prescription Drug Advisory Committee hearing was reinforced by a 2003 survey, finding that almost half of Americans who took over-the-counter NSAIDs in the last year took more than the recommended dose, thus increasing their potential for side effects.
"Consumers can help prevent health problems by reading medication labels and following instructions. Also, proton pump inhibitors, medications that decrease stomach acid, can reduce the risk of NSAID side effects. Other options include taking acetaminophen instead of a NSAID or taking one of the newer NSAIDs, including meloxicam and COX-2 inhibitors, which may cause fewer stomach problems," he notes.
The American Pharmacists Association is a partner to AGA on parts of the campaign focusing on pharmacist and consumer education.
For more information, visit the campaign's Web site: www.2REDUCE.org.