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FDA warns naproxen users

Contact doctor, avoid prolonged use


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ATLANTA, Georgia (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. (Full story)

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

Helmut Schdefers, a spokesman for Bayer Healthcare AG, makers of Aleve, said the company was notified late Monday night about the tests. The company has not yet seen the data, he told CNN, but is investigating the matter.

"We are in agreement with FDA regulators that people taking Aleve should consult their doctors and avoid taking the drug for more than 10 days," he said. "Aleve is particularly disturbing because it's an over-the-counter drug,"

FDA drug safety researcher and whistleblower David Graham told CNN's "American Morning," "Over-the-counter drugs are supposed to be the ones that are the absolutely safest."

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 it has disputed the findings and has kept the drug on the market for now.

Graham said the recent issues surrounding the medications point to larger problems at the FDA, such as a lack of agency accountability. The agency, he said, remains in denial about problems with the way drugs are approved.

"I think this asks the larger question, 'Why has FDA not done the job it needs to do to protect America from unsafe drugs?' " he said.

Graham said in his 20 years at the FDA, "safety has been at the back of the bus, if it's on the bus at all."


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