Naproxen, which is sold over the counter to millions, is the active ingredient in Bayer's Aleve and in Roche's Naprosyn, both over-the-counter pain relievers. In February 2005, naproxen received approval from the government advisory panel meeting that examined the safety of prescription pain relievers.

In December 2004, investigators released early data from a clinical trial known as ADAPT (The Alzheimer's Disease and Prevention Trial), which indicated that naproxen might contribute to a 50% increase in heart attacks and stroke. In response, the government suspended the use of naproxen in the trial.

"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. Cryer testified on the first day of the U.S. Food and Drug Administration (FDA) hearings. Cryer and other physicians, however, started looking at the statistics, 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.

This unsettling news came in the wake of Vioxx's removal from the market and mounting evidence against Celebrex and Bextra. Many people who had been taking the newer cox-2s had started turning to NSAIDs, such as Aleve for arthritis pain relief.

While the announcement in December that Aleve might result in heart problems made the headlines, the apparent vindication of the drug at the FDA panel hearings has been largely overlooked. Bayer HealthCare, the company that makes Aleve, is doing its part to spread the word, however. "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."

Experts are still cautioning people to use products such as Aleve or Naprosyn in moderation, however. "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."

"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."