Naproxen Lawsuits

Naproxen is part of the class of drugs known as nonsteroidal anti-inflammatory drugs, or NSAIDs. Manufactured by Bayer and sold under the brand name Aleve, as well as Roche Palo Alto’s 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.

Naproxen warnings confused both doctors and patients alike. Stemming from a National Institutes of Health funded trial studying the effects of Celebrex, naproxen and a placebo in patients at risk for Alzheimer’s 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 study’s 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 Alzheimer’s 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.

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