The US Food and Drug Administration (FDA) issued a warning about the generic drug naproxen late Monday, after the National Institutes of Health (NIH) halted a clinical trial involving patients at risk of developing Alzheimer's Disease.
Naproxen, a non-steroidal, anti-inflammatory drug, is sold under a variety of brand names, including Aleve, from Bayer and Naprosyn, from Roche. The NIH on Monday announced it had suspended until further notice the use of both naproxen and the COX-2 inhibitor celecoxib, marketed by Pfizer as Celebrex, in a large, three-arm, national Alzheimer's disease prevention trial.
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The trial was designed to assess the potential long-term use of the two drugs in decreasing the risk of developing Alzheimer's disease in people 70 years of age or older who were considered to be at increased risk because of family history but did not have symptoms of the disease.
Increased risk
Preliminary information from the study showed some evidence of increased risk of cardiovascular and cerebrovascular events in patients taking naproxen versus a placebo, the NIH reported.
Patients taking over-the-counter naproxen should carefully follow the label instructions and should not take the naproxen for longer than 10 days, the FDA warned.
Naproxen first was sold as a prescription drug under the trade name Naprosyn in 1976. The FDA approved its use as an over-the-counter drug in 1994. No significant risk was found in the trial for patients taking celecoxib, according to the NIH, but the use of these drugs in the study was suspended in part because of findings reported last week from a National Cancer Institute trial to test the effectiveness of celecoxib in preventing colon cancer.
Rise in heart attacks
US drug giant Pfizer said Friday that a trial had found a sharp rise in heart attacks for patients using Celebrex, its arthritis and pain medicine, but that it would not immediately withdraw the treatment.
Celebrex is used by 26 million people, according to Pfizer, and is the latest COX-2 type pain drug to face controversy. Vioxx, made by the rival Merck and Company, was withdrawn in September because of increased risk of heart attacks.
Separately, three US doctors on Friday appealed for physicians to stop prescribing Bextra, another COX-2 painkiller by Pfizer, for the same reason. – (Sapa-AFP)
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