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Drug aleve increases stroke heart attack risk { December 21 2004 }

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Naproxen is latest painkiller suspected of health risk
Drug sold as Aleve may increase chance of heart attack and stroke, review finds
- Rick Weiss, Washington Post
Tuesday, December 21, 2004

Washington -- The epidemic of bad news about the potential risks of popular anti- inflammatory medications expanded Monday 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.

Researchers uncovered the potential problem with naproxen on Friday during a quick review of data from a large, 3-year-old National Institutes of Health study. As part of that study, which has intended 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, prompted 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 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 Kweder, deputy director of the Food and Drug Administration's Office of New Drugs, speaking at a hastily convened telephone news conference Monday evening. Naproxen has been on the market since 1976, Kweder noted, and "this is the first evidence we've seen that suggests there is a risk."

German pharmaceutical company Bayer AG, which makes Aleve, issued a statement saying the company was just notified of the trial suspension Monday.

"The company has not yet seen the data and therefore is unable to comment on the study at this time," spokesman William O'Donnell said in a statement. "We are investigating the matter and in the meantime we are in agreement with the FDA's recommendation that consumers carefully follow instructions on the label."

Naproxen is also known by prescription forms Naprosyn and Anaprox.

Kweder and other officials acknowledged Monday 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 also includes such commonly taken medicines as ibuprofen (such as Motrin and Advil) 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 people 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, Breit- ner said, but he characterized the level of evidence as "enough to cause some concerns."

NIH Director Elias Zerhouni also emphasized that the amount of risk deemed acceptable in the Alzheimer's study is smaller than what might be deemed acceptable in day-to-day medical practice. Participants in the study are healthy, so it would be unethical to place them in harm's way on the unproven chance that one of the drugs may help prevent Alzheimer's.

By contrast, Zerhouni noted, it is often appropriate to give people drugs that carry modest risks if those people can clearly be helped by those drugs.

For volunteers in the study, Zerhouni said, "the (potential) benefit did not warrant taking the risk. That's very different than advising patients who really need the drug for pain control."

Nonetheless, FDA officials warned the general public to use NSAIDs only as directed. In the case of over-the-counter NSAIDs, that means not exceeding the doses on the label or taking them for longer than recommended. Patients taking prescription NSAIDs should talk to their doctors to reconsider whether they remain the best drugs for them, officials said -- conceding at the same time that the agency had no definitive data to help doctors make those decisions.

In the Alzheimer's study, participants who received naproxen took 220 milligrams a day, twice a day -- the same dose as in the over-the-counter formulation.

Steven Chen, assistant professor of clinical pharmacy at the University of Southern California, said he thought it would be surprising if naproxen truly increased the risk of heart attacks and strokes. If anything, the drug is supposed to make blood clots less likely because it decreases the stickiness of platelets in the blood, he said.

Chen said that the withdrawal of the painkiller Vioxx earlier this year because of increased cardiovascular risk did not come as a surprise because studies had already shown that it raised the risk of heart attacks and stroke. The same was not the case for naproxen.

"It's the first time we've seen anything like this with Naprosyn," he said, referring to the drug by its prescription brand. "I think it will likely surprise the medical community, but I don't think anybody will take it to heart unless it can be substantiated" by another study that was designed specifically to look at effects of the drug upon the heart.

Kweder said the FDA was not considering any immediate regulatory action regarding naproxen, pending further review.


Four big-selling pain medicines have fallen under suspicion in recent months of possibly causing heart problems.

Aleve: Also known as naproxen, this Bayer AG-made painkiller might increase risk of heart attack or stroke, federal officials say.

Celebrex: A federal cancer prevention study found a strong indicator of heart risk among patients taking high doses of this leading arthritis painkiller, which is made by Pfizer Inc.

Vioxx: In September, maker Merck & Co. withdrew this painkiller, a Celebrex competitor, after a study found that it increased the risk of heart attack and stroke by more than 100 percent.

Bextra: Pfizer says a study of the drug found that it increased the risk of heart attacks in those who have had cardiac surgery.

Source: Chronicle news services

The Los Angeles Times contributed to this report.

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