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Aleve Side Effects

Aleve is the brand name of the generic drug naproxen that is manufactured by Bayer. First sold by prescription in 1976, Aleve was later approved for over-the-counter sales in 1994. Since then, there has been no knowledge of significant Aleve side effects, but on December 20, 2004, the National Institutes of Health (NIH) announced it was suspending the use of Aleve from its study after finding patients taking the drug when compared to those taking a placebo have about a 50 percent greater chance of suffering strokes or heart attacks.

The Aleve side effects were considered great enough by the investigators that they could not continue to administer the drug until resolving questions. Aleve was the only medication used in the study, but the FDA says the warning pertains to all drugs that contain naproxen as the active ingredient. While some doctors are skeptical that significant Aleve side effects exist considering the drug has been on the market for decades, Dr. Gregg C. Fonarow, professor of cardiovascular medicine at UCLA noted these medicines were originally studied in the short term for treatment of pain, and their cardiovascular effects were never really well scrutinizedNow theyre being used in higher doses longer term, and were seeing they indeed can increase the risk for myocardial infarction and strokes.

The trial is suspended until more information is gathered since no one knows for sure why the Aleve side effects developed, or if the Aleve side effects are an indicator that all NSAIDs carry cardiovascular risks. NSAIDs, or nonsteroidal anti-inflammatory drugs, are the class of drug Aleve and other naproxen drugs belong to. Because heart attacks normally develop from a blood clot that forms in the blood vessels that supply these organs, the NSAIDs may increase the likelihood of developing such a blood clot, which researchers are trying to better understand the link.

The study was designed to assess the potential benefit of long-term use of Aleve and Celebrex compared to a placebo in decreasing the risk of developing Alzheimers disease in people 70 years of age or older considered at increased risk for the disease because of family history. In addition to the evidence that increased cardiovascular Aleve side effects were present, research investigators also suspended the use of Celebrex from the study after a separate federal study on cancer prevention found a strong indicator of heart risk among high dose Celebrex patients.

Celebrex belongs to the same class of NSAID drugs as Aleve, but more specifically to a subset of NSAIDs called Cox-2 inhibitors. The FDA warning that Aleve side effects may include increased heart risks has been made at an especially controversial time for both the drug industry and the federal drug agency regulating it. At the close of September 2004, Vioxx, another Cox-2 inhibitor, was recalled from the market in the largest prescription drug recall of all time.

The focus after the Vioxx recall soon expanded to questioning the safety of all Cox-2 drugs when shortly after, the FDA warned increased drug warnings were being placed on Bextra labels, a Cox-2 inhibitor as well. The Celebrex announcement made December 17, 2004 put further scrutiny and criticism on drug safety. If cardiovascular Aleve side effects do exist, the heart attack and stroke risks seen in Cox-2 drugs could possibly include all drugs in the NSAID class of drugs.

The FDA advised doctors at the time of the Celebrex warning to seek alternative treatment methods for patients, but the agency stopped short of issuing a similar warning about the possible Aleve side effects. Officials did warn patients to consult with their doctors and to carefully follow drug instructions and avoid taking Aleve for more than 10 days.

For more information on naproxen and aleve side effects, please contact us to confer with a Naproxen Lawyer and learn your legal rights and options.

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