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Aleve Ingredient Seen as Health Risk

December 21, 2004
The news for pain sufferers isn't getting any better. After one prescription pain reliever has been pulled from the market and questions raised about two others, the Food and Drug Administration has stropped a study involving naproxen, an over-the-counter remedy used by millions. It's the active ingredient in Aleve and Naprosyn.

Naproxen • Naproxen Seen as Health Risk --- Other NSAIDs • Bextra • Celebrex • Vioxx

Researchers discovered the problem last week during a review of data from a large three-year-old study of whether anti-inflammatory drugs can delay the onset of Alzheimer's disease. The National Institutes of Health stopped the study when the data showed a 50 percent increase in heart attacks and strokes among study participants taking naproxen compared with those taking placebos.

A Food and Drug Administration (FDA) official said it was the "first evidence" suggesting a risk since the drug was introduced in 1976. But she acknowledged that there have been no long-term studies of the safety of naproxen or any of the other popular nonsteroidal anti-inflammatory drugs (NSAIDs).

Until now, the NSAID safety issue had been limited to the so-called COX-2 inhibitors, Vioxx, Celebrex and Bextra.

The FDA has not issued a warning about Aleve or any other naproxen product, but has advised consumers who are taking it to carefully follow the instructions on the label. Patients should not exceed the recommended doses for naproxen (220 milligrams twice daily) and should not take naproxen for longer than ten days unless a physician directs otherwise.

Patients with questions about naproxen should consult their physician.

Non-steroidal anti-inflammatory drugs like naproxen are used for the management of mild to moderate pain, fever, and inflammation. They work by reducing the levels of prostaglandins, chemicals that are responsible for pain, fever and inflammation. Naproxen blocks the enzyme that makes prostaglandins. Naproxen was first sold as a prescription drug under the trade name Naprosyn in 1976. FDA approved its use as an over-the-counter drug in 1994.

Vioxx was withdrawn from the market in September after its maker, Merck, said studies indicated use of the drug, most often prescribed for arthritis pain, might increase the risk of heart attack and strokes in people taking it for long periods of time. More recently, questions have been raised about Bextra and Celebrex, with the latter's advertising suspended this week.

While the drug's manufacturer, Pfizer, continues to express confidence in Celebrex, concerns about its possible health risks were enough to prompt the National Cancer Institute to suspend clinical trials in which patients were taking Celebrex.

The NSAID class also includes ibuprofen (often sold as Motrin and Advil) and, for that matter, aspirin.

Researchers warned the association between naproxen and heart attacks and strokes among study participants may be a fluke. More research will be needed to answer that question.

Patients taking over-the-counter naproxen should carefully follow the label instructions and should not take naproxen for longer than 10 days, the FDA warned.

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