Naproxen Warning News

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December 20th, 2004

"FDA issues new drug warning statement on naproxen (Aleve)"

The FDA says it is working with the National Institutes of Health to review available scientific information on naproxen, sold under the brand name Aleve by Bayer, after the decision to halt a clinical trial studying the effect of naproxen on patients at risk of developing Alzheimer’s disease was made. The decision came when preliminary information from the study showed some evidence of increased risk of cardiovascular events when comparing patients taking naproxen to a placebo.

Naproxen users were 50 percent more likely to have heart attacks or strokes. Part of a class of drugs known as nonsteroidal anti-inflammatory drugs, or NSAIDs, naproxen is used for a wide variety of ailments. The study’s principal investigator, Dr. John Breitner, says that he has more questions than answers because “we’ve never had the opportunity to study that,” and now researchers are questioning the safety of all NSAID drugs, not just naproxen.

The FDA is advising patients currently taking naproxen to carefully follow instructions on the label and avoid taking doses higher than recommended. In addition, the agency warns naproxen should not be taken for longer than ten days unless a physician directs otherwise.