Arthritis Drug Vioxx® Linked to Heart Attack Risk

The FDA has approved the use of Vioxx® (rofecoxib) for rheumatoid arthritis adding the indication to the previously approved indications for osteoarthritis and pain, even though the study found that there was more than a two-fold higher cumulative rate of serious cardiovascular adverse events (such as heart attacks, angina, and clots) in the Vioxx® group (1.8%) compared to the naproxen group (0.6%). This popular class of anti-inflammatory drugs, known as COX-2 inhibitors, or coxibs, were designed to be easier on the stomach than aspirin and other arthritis drugs, but are now known to increase your risk of heart attack, researchers caution.

This is not the first study to show that Vioxx® increases the risk of heart attacks. A study in August of 2001, first found this association (he Journal of the American Medical Association 2001;286:954-959.). This time the FDA and the Arthritis Advisory Committee agreed to recommend that the label for Vioxx® should include gastrointestinal and cardiovascular WARNINGS. The warning advises patients and their doctors about the risks of GI ulcers, bleeding, and perforation as well as the Cardiovascular findings. The new label provides information from studies of patients with rheumatoid arthritis at the chronic dose of 25 mg, showing that Vioxx® was associated with a higher incidence of hypertension compared to naproxen 1000 mg.

In addition, the geriatric section of the label will reinforce information in the existing standard warning section of all NSAIDs indicating that the elderly are at higher risk of serious gastrointenstinal and kidney side effects, including GI bleeding and acute kidney failure. For information about joint and heart healthy natural alternatives. For information about natural alternatives, please click here: