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Aleve Ingredient Joins Painkillers Linked to Risks

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, Breitner said, but he characterized the level of evidence as "enough to cause some concerns."

NIH Director Elias A. 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 he noted, it is often appropriate to give people drugs that carry modest risks if those people can clearly be helped by those drugs.

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.

_____The Heart_____
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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 took the opportunity to warn the 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.

Kweder said the FDA was not considering any immediate regulatory action regarding naproxen, pending further review. And yesterday's announcement was made after the close of financial markets. But the recent market declines for the companies that make Celebrex and Vioxx do not bode well for naproxen's makers, including Roche (which makes prescription Naprosyn) and Bayer HealthCare, which makes Aleve.

Bayer spokesman William O'Donnell said the company was notified of the trial suspension yesterday and has not yet seen the data.

Bayer "is unable to comment on the study at this time," he said. "We are investigating the matter, and in the meantime we are in agreement with the FDA's recommendation that consumers carefully follow the instructions on the label."

Pfizer's stock tumbled again yesterday, closing at $24.49, down $1.46, or 5.7 percent. The stock has now fallen more than 15 percent since Thursday.

Annual sales of Aleve were $148 billion, according to a Dec. 20 report from Brand Week.

Staff writer Brooke A. Masters contributed to this report.

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