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Aleve Ingredient Joins Painkillers Linked to Risks

By Rick Weiss
Washington Post Staff Writer
Tuesday, December 21, 2004; Page A01

The epidemic of bad news about the potential risks of popular anti-inflammatory medications expanded yesterday as federal officials announced that naproxen, a painkiller sold by prescription and also over the counter as Aleve, might increase people's risk of having a heart attack or stroke.

The new findings bring to three the number of widely used anti-inflammatory drugs suddenly in the spotlight for their potential health risks. Vioxx was pulled from the market this fall, and its sister drug Celebrex, the blockbuster arthritis drug, was linked to heart attacks and strokes last week, stopping a major clinical trial.

The long-term safety of popular painkillers known as nonsteroidal anti-inflammatory drugs has not been studied. These include such common over-the-counter medicines as ibuprofen. (Tannen Maury -- Bloomberg News)

Aleve Risks:
In study, more heart attacks and strokes occurred in patients taking naproxen, known over the counter as Aleve.

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Researchers uncovered the potential problem with naproxen on Friday during a quick review of data from a large, ongoing three-year-old National Institutes of Health study. As part of that study, which has aimed to see if anti-inflammatory drugs can help delay the onset of Alzheimer's disease, 2,500 elderly people have been receiving regular doses of naproxen or Celebrex.

The Alzheimer's study review, triggered by Celebrex's recent woes, surprised officials by revealing a 50 percent increase in heart attacks or strokes among study participants taking naproxen compared with those who had been taking placebos. There were no apparent increases in those life-threatening events among those taking Celebrex -- a reassuring if somewhat confusing finding in light of other evidence to the contrary.

With many volunteers already expressing unease about their ongoing participation in the Alzheimer's study because of the recent reports on Celebrex, and with new evidence suggesting naproxen may have problems of its own, NIH officials and study leaders decided to suspend both parts of the study as a "precautionary measure."

Officials emphasized that they are still not sure what to make of the preliminary findings.

"This is a very confusing situation," said Sandra L. Kweder, deputy director of the Food and Drug Administration's Office of New Drugs, speaking to reporters at a hastily convened telephone news conference yesterday evening. Naproxen has been on the market since 1976, she noted, and "this is the first evidence we've seen that suggests there is a risk."

She and other officials acknowledged, however, that no one seems to have studied the long-term safety of naproxen or, for that matter, any of the other popular painkillers known as nonsteroidal anti-inflammatory drugs, or NSAIDs. It is a large class that includes such commonly taken medicines as 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.

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