Aleve Newest Drug Linked To Risk

Aleve graphic Naproxen AP

A recent study has raised questions about the safety of the over-the-counter pain reliever naproxen, commonly known under the brand name Aleve, which has been in use for 28 years.

The study, a large exploration into treatments for Alzheimer's Disease, has since been suspended. Researchers found patients taking naproxen had more heart attacks and strokes than others.

The study, involving some 2,500 patients, was to test whether naproxen or Celebrex, both pain relievers, could reduce the risk of Alzheimer's Disease among healthy elderly patients who were at an increased risk of the disease.

Officials at the said the study was suspended after three years when it was found that patients taking naproxen had a 50 percent greater incidence of cardiovascular events — heart attack or stroke — than patients taking placebo.

Another factor, officials said, was the announcement last week that advertising for Celebrex was being halted after a study found that high doses of the drug were associated with an increase in heart attack risk. Preliminary data from the Alzheimer's study, however, did not indicate an increased risk for heart attack or stroke for Celebrex, officials said.

With these warning signs against popular medications, many patients, such as arthritis sufferer 78-year old Ruth Birn, are left wondering what their options are. CBS News Correspondent , who said, "I'm concerned, but what else am I going to take?"

Although much of the evidence against the popular drugs hasn't turned into formal warnings against their use, Dr. Elias Zerhouni, the head of the National Institues of Health, advises using caution if perscribed one of the recently criticized drugs.

"My advice I would give to the public is this: do not use these drugs for longer than you need them at doses higher than are recommended," Zerhouni said.

Despite this and other news showing the danger of popular medications and directing scrutiny at the FDA, most Americans say they're at least somewhat confident about the safety of prescription drugs sold in the United States, according to an Associated Press poll taken at a time when several popular medications have been linked to increased risk of heart attack and stroke.

Just more than eight in 10 said they have confidence in the general safety of prescription drugs in this country, the poll conducted for the AP by Ipsos-Public Affairs found. Almost that many said they have confidence in the FDA.

Celebrex, a prescription drug, and naproxen are both commonly used to treat the joint pain of arthritis. Naproxen has been approved for sale, first as a prescription and then as an over-the-counter drug, since 1976. Celebrex is in the same class — COX2 enzyme inhibitors — as Vioxx, an arthritis drug recently taken off the market by its manufacturer after it was linked to an increase in heart attack and stroke.

The FDA plans a meeting in February to get to bottom of the COX2 problem, reports CBS News Medical Correspondent Dr. Elizabeth Kaledin. The hope is the public will soon have an answer whether these drugs do more harm than good.

"What this kind of information does is kind of raise a flag that says be careful with drugs," Stuart Schweitzer, a professor of health services at UCLA and a specialist in pharmaceutical policy, told CBS Radio News. "There aren't any completely innocuous drugs.

"It appears to be getting more and more difficult to find really safe drugs for common diseases," Schweitzer said.

Dr. Sandra Kweder of the Food and Drug Administration said the NIH study is the first to show that naproxen might increase the risk of heart attack or stroke and that the findings are "confusing." No immediate action, however, is expected toward naproxen, she said.

"We are not contemplating any specific regulatory action over the next few days," said Kweder. "We will be working with the NIH to try to understand the data better and determine what will be appropriate from there."

She said patients who routinely take naproxen should follow the drug package instructions carefully, including the directions to not take it for more than 10 days, and to consult a doctor if pain persists.

"If a patient needs a drug and derives a lot of benefit from it, and if the absolute risk of this side effect is still small, then the advice probably should be to continue using that drug," said Schweitzer.

Otherwise, "I guess we go back to aspirin, and there the problem is that some patients do have a gastric, a stomach reaction," he added.

In the earlier studies of the COX2 drugs, an increase in cardiovascular events was noted only after a long-term use of the medications.

The Alzheimer's disease study was being conducted by the National Institute on Aging, an arm of the NIH. It called for 2,500 patients aged 70 or older and who had a family history of Alzheimer's, to take either Celebrex, naproxen or a placebo.

The group was divided and each division, or arm, was assigned to receive one of the drugs or placebo. The drugs were blinded, which means the patients did not know which medication they were taking, or if they were taking a placebo.

The goal was to determine if the pain-relieving drugs lowered the risk of developing Alzheimer's disease. The study started three years ago and was to continue for a few more years. Officials said the patients in the study will be monitored for developing Alzheimer's or cognitive decline, but will not be given the test drugs.

John Breitner of the Veterans Affairs medical facility in Seattle and the University of Washington, an investigator in the trial, said only preliminary data is available. But he said it suggests that among the 2,500 patients in the study, about 70 suffered stroke or heart attack. There were 23 deaths. There were 50 percent more of the cardiovascular events among patients taking naproxen than among those taking placebo, he said.

"With Naproxen, we've been doing very large clinical trials, and large clinical trials tend to uncover side effects that were there all along, but we didn't notice them," said Schweitzer.
  • Chris Hawke

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