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drug_recall naproxenNaproxen is a non-steroidal anti-inflammatory drug (NSAID) that has been on the United States market since 1976 to treat the pain, inflammation and stiffness associated with many conditions including arthritis, gout, tendonitis, bursitis, injury, and menstrual cramps. Naproxen is available in both over-the-counter (Aleve) and prescription strength (naprosyn and anaprox).
Food and Drug Administration officials announced on December 20, 2004 that recent clinical study evidence indicates that patients taking naproxen may be at an increased risk of suffering heart attack or stroke. In this study conducted by the National Institutes of Health, researchers were testing the effectiveness of naproxen and another drug called Celebrex in preventing Alzheimer’s disease. The ADAPT study began in 2001 and was a three year study with 2500 elderly participants. The clinical trial was halted because researchers found a fifty percent increase in the risk of heart attack or stroke for people taking naproxen compared to patients who were taking a placebo.
Clinical trial researchers, federal regulators, and naproxen pharmaceutical companies are all looking into this possible risk of serious cardiovascular complication associated with naproxen use. This naproxen study has surfaced amidst major concerns about the cardiovascular safety of newer NSAIDs, particularly Vioxx (which was recalled in September 2004 because of cardiovascular risks) and Celebrex (a drug that has also been linked to cardiovascular risks).
These two COX-2 selective NSAIDs were originally developed to be gentler on the gastrointestinal system than original NSAIDs like naproxen and ibuprofen. Naproxen and other non-selective NSAIDs have long been known to cause ulcers and other gastrointestinal complications. Common side effects from naproxen include: nausea, headache, dizziness, constipation, heartburn, shortness of breath, and edema. Gastrointestinal problems from naproxen are less common but are generally indicated by symptoms of black or bloody vomit or stools. Severe allergic reaction is a very rare side effect associated with naproxen use.
This recent study is the first time that naproxen has been associated with an increased risk of cardiovascular complications. It is still unclear from preliminary evidence the exact statistical significance of these naproxen findings. What researchers do know is that the 50 naproxen patients who suffered adverse cardiovascular events in the clinical trial were over the age of seventy and were taking doses of naproxen that were equal to the standard over-the-counter dose of naproxen.
The results of these naproxen risk findings are still being studied and no results have been substantiated yet. If you or a loved one is taking naproxen and you are concerned about potential naproxen cardiovascular risks, you may wish to consult with your physician who can address your concerns. If you have suffered a heart attack, stroke, or any adverse physical event as a result of taking naproxen, you may wish to contact an attorney who can advise you of your legal rights in a case to recover what you have lost.
The FDA says it is working with the National Institutes of Health to review available scientific information on naproxen, sold under the brand name Aleve by Bayer, after the decision to halt a clinical trial studying the effect of naproxen on patients...