Pain Drug Naproxen Poses Heart Risk, U.S. FDA Says

The U.S. Food and Drug Administration on Monday issued a warning to patients taking the painkiller naproxen after a government study showed the over-the-counter medicine can cause an increased risk of heart problems.

Patients taking naproxen, which is sold as a generic drug and under the brand names Aleve, Naprosyn and others, should not exceed the recommended dose and should not take it for more than 10 days unless directed by their doctor, the FDA said in a statement. The news follows studies showing increased heart risks in two prescription painkillers. Merck & Co. Inc. withdrew its arthritis drug Vioxx in September. Pfizer Inc. has kept its arthritis medicine Celebrex on the market, but has suspended consumer advertising. The results were part of a National Institutes of Health trial studying certain anti-inflammatory drugs in patients at risk for Alzheimer’s disease. The trial, which included Celebrex, was halted after early results showed a higher risk of cardiovascular problems. Celebrex showed “no significant increase” in risk for cardiac trouble or stroke in the trial, the NIH said. Bayer AG makes Aleve, and Roche Palo Alto, a subsidiary of Roche AG, makes Naprosyn. Naproxen and Celebrex are in a group of drugs called nonsteroidal anti-inflammatory drugs that includes aspirin and ibuprofen. Within that group, Vioxx and Celebrex are part of a class known as Cox-2 inhibitors, along with Pfizer’s Bextra. (Source: Reuters Health: December 2004.)