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FDA Warns Naproxen Users

Dec 21, 2004 | CNN

The Food and Drug Administration issued a warning to users of the over-the-counter pain reliever naproxen Monday after federal researchers found an increased number of heart attacks and strokes among users.

The warning followed recent studies linking two prescription arthritis drugs to cardiovascular problems.

Naproxen, sold under the brand name Aleve, was part of a study by the National Institutes of Health into whether naproxen or the arthritis drug Celebrex could be used to treat Alzheimer's disease. NIH researchers halted the survey after finding people who took naproxen were 50 percent more likely to have heart attacks or strokes.

The FDA urged users to contact their doctors and to avoid taking the drug for longer than 10 days.

But the NIH study appeared to contradict a National Cancer Institute study last week that found that Celebrex users had a higher risk of heart attack or stroke. The NIH did not find a higher likelihood of those problems in Celebrex users.

Friday, the FDA warned doctors to consider "alternative therapy" for patients taking Celebrex after cancer researchers found a higher risk of cardiovascular problems among patients taking the drug.

The FDA statement said another painkiller, Bextra, has also shown increased risks of cardiovascular events following heart surgery.

Last week's findings came more than two months after drug manufacturer Merck recalled a similar arthritis drug, Vioxx, after similar results. Merck now faces hundreds of lawsuits and potentially billions of dollars in damages.

Vioxx, Bextra and Celebrex are from a family of drugs known as Cox-2 inhibitors, which have been heavily advertised to potential patients. Pfizer pulled ads for Celebrex, but has disputed the findings and has kept the drug on the market for now.


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