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Naproxen 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 a non-steroidal anti-inflammatory drug (NSAID). Naproxen is accessible in both over-the-counter (Aleve) and prescription strength (naprosyn and anaprox).

Food and Drug Administration (FDA) officials declared on December 20, 2004 that current clinical study facts indicate that individuals taking naproxen may be at an increased risk of suffering heart attack or stroke. In this analysis 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 three year study began in 2001 with 2500 elderly participants. The clinical trial was stopped because researchers established a fifty percent increase in the risk of heart attack or stroke for people taking naproxen compared to patients who were consuming a placebo.

Federal regulators and naproxen pharmaceutical companies are all looking into this potential risk of serious cardiovascular complication connected with naproxen use. This naproxen study has emerged 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 initially developed to be gentler on the gastrointestinal system than the previous NSAIDs like naproxen and ibuprofen. Naproxen and other non-selective NSAIDs have been recognized for causing ulcers and other gastrointestinal problems. 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.