Aleve linked to heart attacks
By Rita Rubin
USA Today
The popular over-the-counter pain reliever Aleve has been linked to an increased risk of heart attack and stroke in a National Institutes of Health study, the agency announced yesterday.
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, Galson said.
Participants, some of whom had been taking the drug for nearly three years, have been told to stop taking their pills, but researchers will follow them for an undetermined length of time, said lead scientist John Breitner of the University of Washington.
FDA guidance
Patients in the study were given 220 milligrams of Aleve twice a day, the same dose recommended for over-the-counter use.
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 drug makers to conduct long-term safety studies. Naprosyn, the prescription version of Aleve, has been on the market since 1976, Aleve since 1994. The generic name for the drug is naproxen.
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," said Steven Galson, acting director of the Food and Drug Administration's drugs division. The FDA is working closely with the NIH to review all available scientific information on 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 percent higher risk of heart attacks and strokes in those on Aleve than in those on a placebo, Breitner said.
Yesterday's 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.
Steven Chen, assistant professor of clinical pharmacy at the University of Southern California, said he thought it would be surprising if Aleve/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 already had 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.
The Los Angeles Times contributed to this report.
