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Naproxen (Aleve)

Naproxen is part of the class of drugs known as nonsteroidal anti-inflammatory drugs, or NSAIDs. Manufactured by German drugmaker Bayer and sold under the brand name Aleve, as well as Roche Palo Altos Naprosyn, naproxen was first sold by prescription in 1976 and was approved for over-the-counter sales in 1994. The popular over-the-counter drug is used to treat a variety of ailments, including headaches, menstrual cramps, arthritis and gout. Amidst drug safety warnings and controversy, naproxen is the latest drug to be added to the list of questionable medicines.

A subset of NSAIDs, called Cox-2 inhibitors, include the now recalled Merck & Co. drug Vioxx and Pfizer Inc.s Celebrex and Bextra. Older drugs like aspirin can cause stomach bleeding and ulcers so newer Cox-2 drugs were designed to prevent gastrointestinal side effects. Some medical experts believed naproxen might have beneficial heart effects. In 2000, when increased heart risks with Vioxx first surfaced, Merck argued the study results appeared skewed for Vioxx users only because it was compared to the protective heart effects of naproxen other patients included in the trial were taking.

Vioxx was recalled four years later on September 30, 2004 in the largest prescription drug recall of all time after another study showed a significant increase in risk for heart attack and strokes. Just 11 weeks later, Merck announced its arthritis drug Celebrex, and Vioxx competitor, showed an increase for heart risks. Although Pfizer has continued to stand by Celebrex safety and has kept the drug on the market, on December 20, 2004, Pfizer announced it stopped advertising Celebrex directly to consumers in response to an FDA request. Later, the same day, U.S. health regulators warned that heart risks were also connected to over-the-counter painkiller naproxen.

The naproxen warnings further confused both doctors and patients alike. Stemming from a National Institutes of Health (NIH) funded trial studying the effects of Celebrex, naproxen and a placebo in patients at risk for Alzheimers disease, the trial showed patients taking Aleve were found to have about a 50 percent greater chance of suffering strokes or heart attacks than those taking a placebo. Just days earlier, the NIH study suspended the use of Celebrex in the study after FDA warnings were issued. The latest naproxen developments led researchers to also suspend the use of naproxen among study patients as well.

The NIH late-stage trial began in 2001 and was designed to study 2,625 patients for up to seven years. The studys principal investigator, Dr. John Breitner, said the trial showed a fairly impressive signal of increased risk of heart attack and stroke among naproxen users. Even though the Alzheimers study did not show significant increases in risk for cardiac trouble or stroke for Celebrex patients, the decision to stop using Celebrex in the study was in response to a different NIH study investigating inflammation as a cause of cancer that showed Celebrex more than doubled the risk of heart attack and strokes.

The FDA deputy director of the Office of New Drugs described the naproxen effects to be a very confusing situation, but the agency stopped short of urging patients to seek alternative treatment methods to naproxen, unlike their response to Celebrex heart risks findings. FDA officials did urge patients taking naproxen to following instructions carefully and avoid using the drug 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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