MONDAY, Feb. 28, 2005 (HealthDay News) -- As the spotlight continued to shine on a government panel's recent actions on cox-2 inhibitors, there was some good news for another pain drug that had also experienced some adverse test results.
Naproxen, the active ingredient in Bayer's Aleve and in Roche's Naprosyn, both over-the-counter pain relievers, received a quiet green light from the government advisory panel meeting two weeks ago to examine the safety of the prescription pain relievers.
This had to be a relief from a finding late last year. In December, investigators released early data from a clinical trial known as ADAPT (The Alzheimer's Disease and Prevention Trial), which showed that naproxen might contribute to a 50 percent increase in heart attacks and stroke. All hell broke loose as the government suspended the use of naproxen in the trial, which had been looking at Alzheimer's prevention.
"This led to some pause with respect to naproxen," said Dr. Byron Cryer, an associate professor of medicine at the University of Texas Southwestern Medical Center, Dallas, who testified on the first day of the U.S. Food and Drug Administration (FDA) hearings. Cryer and others, however, started doing the math and realized the findings would have been statistically impossible in that particular setting.
It seems more likely, Cryer said, that naproxen has a slight cardioprotective effect.
On the last day of the hearings, Dr. Steve Nissen of the Cleveland Clinic, a member of the advisory panel, said the hue-and-cry on naproxen, sold over the counter to millions, had been tantamount to yelling fire in a crowded theater.
The timing of the news was particularly bad, coming as it did in the wake of Vioxx's departure from the market and damning evidence on Celebrex and Bextra. Many people who had been taking the newer cox-2s had recently turned to traditional NSAIDs such as Aleve for help.
But while the announcement in December that Aleve might cause heart problems hit the headlines, the apparent vindication of the drug at the FDA panel hearings was barely a whisper.
Needless to say, this is news that Bayer HealthCare, which makes Aleve, has pounced on. "Much of the reason why the ADAPT study was stopped was because of operational issues and recruitment -- not because of perceived safety issues with respect to naproxen," said Erica Peitler, senior vice president of research and development at the company's headquarters in Morristown, N.J. "At this point, it is unadjudicated and we are anxiously awaiting to see what the data shows."
But even if, at least for the time being, naproxen has been absolved of cardiac risk, there's still no reason to go overboard on Aleve or Naprosyn, experts said.
"The safety profile of naproxen is as good as any other one," said Dr. Kevin R. Stone, an orthopedic surgeon with the Stone Clinic in San Francisco. "What has been overlooked is that all of the NSAIDs inhibit bone healing and tendon healing. It's part of the risk.
"People need to follow the guidelines on the label and not take it more than 10 days unless advised by a doctor," added Dr. Jason Theodosakis, an assistant professor at the University of Arizona College of Medicine and author of The Arthritis Cure. "The problem is when people see it's approved, that it's advertised and that it's sold everywhere over-the-counter, they view it as being safe. That clearly is not the case. Some of these drugs can be deadly. Everybody is an individual. You have to weigh the risk-benefit ratio."
Theodosakis tends to see NSAIDs of any kind as a last resort. "My career has been heavily focused to keep people off of drugs and off of surgery," he said. "I find other alternative ways for patients to manage pain." That might include exercise, diet and certain supplements that are sold as medications in Europe, such as glucosamine. Glucosamine is sold in the United States as a food supplement and is as widely available as aspirin, ibuprofen and naproxen.
"The hearings have brought the whole awareness of adverse events to a very prominent position," said Dr. David A. Peura, president-elect of the American Gastroenterological Association. "The irony is that the coxibs were developed as a safer alternative to drugs like naproxen. And they are safer in one system, but there may be some flaws. I hope what this does not do is push people at high risk to start taking the medication."
"As with all of the traditional NSAIDs, naproxen does have the potential for causing gastrointestinal side effects," Peura added. "Risk is sort of relative. There's a whole range of [possible] side effects. Naproxen tends to be one of the safer NSAIDs. It is effective. It's rapidly available. We've had a long experience with it, but patients need to use it judiciously if they have risk factors. That's been the case all along."
More information
The American Academy of Orthopedic Surgery has more on NSAIDs.
