Walter Scarborough knows what awaits him if Celebrex is taken off the market.

“Let me tell you how bad my chronic pain was,” says Scarborough, a 69-year-old Houston businessman who used to walk – very slowly – with a cane. “I never escaped it. Even when I was asleep I was aware that I hurt.”

When his rheumatalogist prescribed Celebrex several years ago, Scarborough felt better almost immediately. In two to three weeks he tossed away his cane. One of the first patients to go on the popular prescription pain drug, he had suffered many years with arthritis, tried numerous other medications and found little relief. Now it may be only a matter of time before the controversial drug is no longer available.

Like Vioxx and Bextra, Celebrex is a non-steroidal anti-inflammatory drug (NSAID) called a COX-2 inhibitor. Until recently, these drugs were widely prescribed for arthritis and inflammation because they provide both pain relief and fewer gastrointestinal (GI) problems. But both Vioxx and Bextra have been taken off the market after studies showed that they may increase the risk of heart attacks and strokes. In addition, the FDA reports that Bextra appears to cause rare but serious skin conditions – some fatal.

Doctors can still prescribe Celebrex for their aching patients, but perhaps not for long. When Bextra was yanked off the market in early April, the FDA also ordered that Celebrex and other popular pain medications carry tough new warnings that they, too, may increase the risk of heart attacks and strokes.

But banning the only COX-2 inhibitor still available would be a serious problem for some of his patients, says Frank C. Arnett, M.D., professor of internal medicine at The University of Texas Medical School at Houston, and Elizabeth Bidgood Chair in Rheumatology.

“These were very useful drugs,” says Arnett. “I’m not so sure they were any better in terms of pain relief than the older anti-inflammatory drugs, but they were safer in terms of stomach problems.”

Hedging Your Bet

Many medical authorities agree that the biggest virtue of the COX-2 inhibitors is not pain relief, in fact, but fewer GI problems. And studies show that they are no more effective at relieving pain than such over-the-counter (OTC) anti-inflammatories as Aleve and Advil, drugs that also fall into this new category of concern.

Walter Scarborough, however, respectfully disagrees, as do some other arthritis sufferers. One 71-year-old woman who took various drugstore OTC medications for her aching neck and shoulders for years with little relief calls Celebrex “a wonder drug.” A physically active woman who walks, swims and plays tennis, she had ongoing aches and pains until her doctor prescribed Celebrex last fall. It took only a couple of weeks before the aching stopped.

When the new warnings about Celebrex were issued, she talked to her doctor about the risks and whether to continue the drug. Her doctor, like Arnett and others, believed the benefits outweighed the risks, suggesting she take a treadmill test to assure that she had a healthy heart and prescribed the lowest Celebrex dosage possible.

For his patients who want to stay on Celebrex, Arnett also prescribes the lowest possible dosage, as well as low doses of aspirin, which may help protect against the cardiovascular risks associated with COX-2 inhibitors.

The Drugstore Blues

Michael A. Altman, M.D. and assistant professor of medicine at the UT Medical School, agrees that aspirin therapy decreases the risk of heart attacks and strokes for Celebrex users as well as for people who take OTC anti-inflammatory drugs. But combining aspirin with either Celebrex or OTC drugs for pain can also increase the risk for bleeding complications, he notes.

So is there no totally trustworthy pain medication out there?

“The safest way would be to use a drug as short a time as possible,” says Altman, who is board-certified in sports medicine. “Or use those known not to cause these problems, such as Tylenol, one of the most underrated drugs for treating acute arthritis pain. You can take up to 4,000 milligrams of Tylenol a day, assuming you don’t have any pre-existing liver problems. That’s two extra-strength tablets four times a day.”

Acetaminophen, the active ingredient in Tylenol is an analgesic with no anti-inflammatory properties. In normal doses, it is deemed safe for patients—who do not have liver disease.

But the pain-relieving properties of Tylenol just weren't effective for people like Walter Scarborough.

And while older, OTC anti-inflammatories, like Advil and Aleve may work to relieve pain and inflammation, they also may carry the same risks as their prescription-only cousins.

In April 2005 the FDA issued a stern request that all NSAIDs, excluding aspirin, carry a “ ‘boxed’ or serious warning to highlight the potential increased risk of CV [cardiovascular] events, and the well known risk of serious, and potentially life-threatening, stomach bleeding.” The FDA has also requested that the package insert for all NSAIDs be restated to warn patients who have just had heart surgery not to take these drugs.

“We don’t know if these drugs [ibuprofen and naproxen, popularly known as Advil and Aleve, among others] carry an accelerated cardiovascular risk because those studies were never done, nobody ever thought of it,” Arnett says, “so, we’re not out of the woods in terms of those drugs. With the newer drugs for pain, there have just been more studies and more media attention.”

The bottom line, says Arnett, is that “every drug has its risks, and if people know the risks and are willing to take them, and have taken steps to assess their health and ability to take these drugs, then, that’s fine.”

For Walter Scarborough, it comes down to quality of life. “What’s the point of being alive if you’re suffering all the time?” he asks. “If I die of a heart attack tomorrow, then at least I’d be comfortable.”

Last Updated: 6-21-2005

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