Dec 21, 2004

Ooooh My back! (naproxen warning)

The FDA stopped short of urging patients to seek alternatives to the large class of drugs. Nonsteroidal anti-inflammatory drugs include ibuprofen (such as Motrin and Advil), naproxen (such as Naprosyn and Aleve) and the COX-2 inhibitors Celebrex (chemical name celecoxib) and Vioxx (rofecoxib).

“It may be a problem for all nonsteroidal anti-inflammatory drugs, because we've never had an opportunity to examine this question,” said John Breitner of the University of Washington and the Veterans Affairs Puget Sound Health Care System in Seattle, the leader of the Alzheimer's study.

Then again, Breitner and others said, some of the warning signals emerging may be false alarms.

In the Alzheimer's study, for example, in which 70 persons experienced a stroke or heart attack out of 2,500 participants, the 50 percent increase in risk seen with naproxen may or may not prove to be “statistically significant” — a scientific term that would suggest the association is not simply due to chance. More analysis needs to be done before that question is settled, Breitner said, but he characterized the level of evidence as “enough to cause some concerns.”