Participants, some of whom had been taking the drug for nearly three years, have been told to stop taking their pills, but researchers will continue to follow them for an undetermined length of time, said lead scientist John Breitner of the University of Washington.

Steven Galson, acting director of the Food and Drug Administration's drugs division, said consumers should take Aleve only as directed on its label: No more than two pills a day. They also should take it for no longer than 10 days, unless a doctor advises otherwise, he said.

Aleve, made by Bayer, is the first non-prescription product to join a growing list of pain relievers linked to heart attacks and strokes. The FDA has come in for criticism for not requiring drugmakers to conduct long-term safety studies. Naprosyn, the prescription version of Aleve, has been on the market since 1976, Aleve since 1994.

Patients taking Naprosyn should talk with their doctor about their risk factors, said Sandra Kweder, deputy director of the FDA's Office of New Drugs.

"Beyond that, I don't think that patients should be overly concerned by the information being conveyed today," Galson said. The FDA is working closely with the NIH to review all available scientific information on naproxen. Aleve is a version of naproxen.

However, Kweder acknowledged that there is little data about the long-term effects of naproxen or any other related pain reliever. "This is a very confusing situation," she said.

The NIH study was investigating whether Aleve or the pain reliever Celebrex could prevent Alzheimer's disease. It found an approximately 50% higher risk of heart attacks and strokes in those on Aleve than in those on a placebo, Breitner said.

The announcement came just three days after the NIH said that a colon polyp prevention trial found more heart attacks and strokes in participants taking Celebrex, compared with those on a placebo.

But the Alzheimer's prevention study, involving 2,400 people 70 and older, has not found an elevated risk of such problems among participants who were taking Celebrex, Breitner said.

Reference Source 106
December 21, 2004

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