What should Vioxx alternative Aleve patients do?

On December 20, the Food & Drug Administration issued an announcement advising people who take an over-the-counter painkilling drug called naproxen (sold as Aleve) to pay attention to instructions on the label and not exceed the maximum recommended dose of 220 milligrams twice daily for more than 10 days without consulting a physician. (Related article: Treatment options for Vioxx patients)

University of Michigan (U-M) physician Mark Fendrick, M.D., agrees that's excellent advice. Fendrick, a University of Michigan physician and professor of internal medicine in the U-M Medical School, has studied the use of non-steroidal anti-inflammatory drugs (NSAIDs) like naproxen and ibuprofen. These are two over-the-counter drugs that have been prescribed for many patients after the recall of Vioxx and warnings about Celebrex and Bextra.

“Long-term use of any non-steroidal anti-inflammatory medication can be dangerous and requires supervision by a medical professional,” Fendrick says. “Anyone taking over-the-counter NSAIDs for chronic pain or inflammation should consult their doctor. People taking these drugs for occasional, intermittent pain should be careful not to take more than the recommended dose.” (Related article: Vioxx type Cox-2 drugs face an uncertain future)

The FDA announcement came in response to the decision by the National Institute of Aging to halt a clinical trial in which non-steroidal anti-inflammatory drugs were given to patients at risk of developing Alzheimer's disease. Preliminary information from the study showed some evidence of higher risks of heart attacks and strokes in patients taking naproxen.

“The FDA's announcement was not a recall. It's just a cautionary statement to patients taking Aleve until full data from the clinical trial can be evaluated,” Fendrick adds. “Given the recent media firestorm surrounding this class of drugs, all chronic NSAID users – OTC and prescription – should discuss the benefits and potential risks of these agents with their physicians to determine the treatment plan which is best for that individual. Hopefully, more information will be forthcoming soon from the FDA regarding the long-term use of naproxen when prescribed by a physician. Until then, I would not suggest that people stop taking their medications.”

Recommended article: Vioxx alternatives Celebrex and Bextra may need to be recalled