# FDA Warns Consumers About Naproxen



## M&M (Jan 20, 2002)

From the Co-Cure Email list:*************************************************FDA Warns Consumers Not To Exceed Naproxen DoseMonday December 20, 7:53 PM ESTWASHINGTON (Dow Jones)--The Food and Drug Administration on Monday warnedconsumers not to exceed the recommended dose of naproxen, a pain reliever in aclass of drugs known as non-steroidal anti-inflammatories, after a clinicaltrial showed that naproxen, sold under the brand name Aleve, might increase therisk of heart attacks and strokes.Earlier Monday, the National Institutes of Health announced that it suspended aclinical trial studying the use of non-steroidal anti-inflammatory drugs andPfizer Inc.'s (PFE) Celebrex in preventing Alzheimer's disease.Preliminary information from the study showed some evidence of increased riskof cardiovascular events, when compared with a placebo, in patients taking 220milligrams of naproxen twice daily. Celebrex was not shown to have increasedthat risk in the Alzheimer's trial, the NIH said. Celebrex did increasecardiovascular risks in another trial that was studying the drug, known as aCox-2 inhibitor, in preventing colon cancer.In a statement, the NIH said the use of Celebrex in the Alzheimer's trial wassuspended in part because of the findings in the colon cancer trial.The FDA said patients who are taking over-the-counter naproxen products shouldcarefully follow the instructions on the label. Patients should not exceed therecommended doses for naproxen, or 220 milligrams twice daily, and should nottake naproxen for longer than 10 days unless a physician directs otherwise.Naproxen was first sold as a prescription drug under the trade name Naprosyn in1976. The FDA approved its use as an over-the-counter drug in 1994.Aleve is a Bayer AG (BAY) product.- By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;jennifer.corbett###dowjones.com Dow Jones Newswires 12-20-04 1953ETï¿½ 2004 Dow Jones & Company, Inc. All Rights Reserved.


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