Is There Life After Vioxx for Arthritis Sufferers?

It was September, 2004 when pharmaceutical manufacturer Merck pulled arthritis pain medication Vioxx (rofecoxib) off the market due to the potential increased risk of heart attack and stroke. Not long after, Bextra, a similar medication, was also recalled. Since then, arthritis sufferers and their physicians have been scrambling to try to find substitute medicines that will allow patients to maintain the quality of life they enjoyed before these medications were recalled.

Vioxx and Bextra are two of several so-called "COX-2 (cyclooxygenase-2) inhibitor" drugs that were introduced in 1999. The COX-2 inhibitors are a subclass of non-steroidal anti-inflammatory drugs (NSAIDs) that have shown a moderate reduction in the side effects - such as gastrointestinal bleeding and ulcers - of other pain relievers. Since their introduction, 91 million prescriptions were written for Vioxx in the United States alone, according to the Arthritis Foundation.

These drugs were a blessing to many of those suffering from arthritis who were unable to take medications such as ibuprofen, naproxen and other NSAIDs because they had a history of stomach irritation, bleeding or ulcers, or because they were taking blood thinners. (Traditional NSAIDs reduce the ability of blood to clot and shouldn't be combined with other blood thinners.)

While the COX-2 drugs did help reduce the incidence of gastrointestinal side effects, other problems surfaced. In drug trials, patients taking Vioxx consistently showed an increased risk for experiencing cardiovascular events such as heart attack and stroke. We now know that the COX-2 inhibitors, like all NSAIDs, can strain the heart by causing the kidneys to retain water, thereby increasing blood pressure. There is another more serious problem: instead of preventing blood platelets from sticking to each other as aspirin does, Vioxx and other such drugs may actually encourage platelets to clump. This promotes clot formation and increases the chances of having a heart attack or stroke.

Prevalence of Arthritis
Arthritis is one of the most common chronic health problems and the leading cause of disability among Americans over age 15. It is second only to heart disease as a cause of work disability, according to the Arthritis Foundation. Nearly 1 in 3 American adults suffers from arthritis or chronic joint symptoms. Little wonder, then, that so many people were depending upon Vioxx and Bextra and are now searching for replacement treatments.

"Prior to the release of the COX-2 drugs, we were treating at-risk patients with acetaminophen or if they were taking an NSAID, then we would add something to minimize stomach problems, like Zantac, Pepcid, Prilosec, or Prevacid, among others," said Paul B. Halverson, MD, FACP, a rheumatologist and Professor of Medicine at the Medical College of Wisconsin. "Now, in light of recent developments, we have to look at each patient and evaluate each situation to determine what is the best course of treatment."

Quality of Life Declines
Unfortunately, some individuals are experiencing a significant deterioration in their quality of life without the COX-2 drugs, said Dr. Halverson. They have not found another drug that gives them the kind of pain relief they enjoyed with Vioxx. "For some of those people, we have to weigh the risks and benefits. Without the medication, their lives have changed so drastically that they can't do the things they were able to do. For those people, we may have to consider whether the benefits outweigh the risks."

General Guidelines
The Arthritis Foundation currently recommends that patients who have a history of heart attack, stroke or chest pain, or those who smoke, have high blood pressure, high cholesterol or a family history of heart disease try a traditional NSAID and something to minimize gastrointestinal distress.

If taking these drugs in the past caused gastrointestinal bleeding or ulcers, you can protect your stomach with a proton pump inhibitor such as over-the-counter Prilosec. Combining an NSAID with a proton pump inhibitor is also a good idea if you take a blood thinner, such as warfarin or a steroid, if you have a high risk of bleeding due to a low platelet count, or if you are elderly.

"What I tell my patients really depends on their personal situation. I will make recommendations based on the patient's whole medical history," said Dr. Halverson. "As always, we have to individualize treatment. We try different things and see how well tolerated they are, what works best for them. The reality is that nothing is free of problems or side effects although the risks are usually minor," he said.

If all of these options fail, trying Celebrex is certainly an alternative, according to Dr. Halverson. "If your quality of life is so much affected, you may end up accepting some risk. Talk to your doctor about what is best for you," he advised.

"Right now, Celebrex is still on the market for those who may still need COX-2 drugs. There have been suggestions that Vioxx might come back, but there are currently lawsuits against the manufacturer," Dr. Halverson said.

FDA More Cautious
"There will continue to be studies, reports and discussions in medical literature about this class of medications," Dr. Halverson said. "There are a couple of other medicines in the pipeline that would have been released if the Vioxx problem had not surfaced. The problems are causing the FDA (US Food and Drug Administration) to be more cautious about releasing new drugs and to require more studies in order investigate possible connections to increased cardiovascular risks."

"The bad thing about all of this is that some people are not doing as well without these medicines," Dr. Halverson said. "We don't want to see people suffer. Unfortunately, because of the uncertainty, physicians are not in agreement about the use of COX-2 drugs. The uncertainty will continue until more research is done."

JoAnn Petaschnick
HealthLink Contributing Writer

Each year, Medical College of Wisconsin physicians care for more than 180,000 patients, representing nearly 500,000 patient visits. Medical College physicians practice at Children's Hospital of Wisconsin, Froedtert Memorial Lutheran Hospital, the Milwaukee VA Medical Center, and many other hospitals and clinics in Milwaukee and southeastern Wisconsin.