The cyclooxygenase inhibitor-2 Vioxx (rofecoxib), used mainly for treatment of arthritis, has been withdrawn voluntarily by the manufacturer from all international markets after realization that the drug raises the risk for myocardial infarction and stroke.

The withdrawal is based on review of new data from a three-year trial assessing whether the drug could act as a chemopreventive for colon cancer by preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas.

Analysis showed that beginning roughly 18 months after initiation of treatment, there was a confirmed increase in relative risk for cardiovascular events such as myocardial infarction and stroke compared with placebo.

In a public health advisory issued from the U.S. Food and Drug Administration, acting FDA Commissioner Dr. Lester M. Crawford said, "although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo."

For patients taking Vioxx, the American Heart Association agrees with Merck's (the manufacturer) and the FDA's recommendation that patients talk with their physician about their cardiovascular disease risk and treatment options for arthritis. "It is important to talk with your physician to determine your risk factors for heart disease and stroke.

Only your doctor can evaluate your individual risk and recommend the best course of treatment, including alternative options for arthritis," said Alice K. Jacobs, M.D., American Heart Association president. "As with any medication for a chronic health problem, it is important to work closely with your physician to monitor your response to the treatment."

The new information may also have value for physicians in risk stratification of patients who had an adverse cardiovascular event while on chronic treatment with Vioxx.