Rofecoxib (Vioxx) withdrawn from markets

Drug maker Merck and Co. pulled off its widely used arthritis drug Rofecoxib (Vioxx) in response to reports that the drug doubled the risk of heart attack and stroke in long-term users. The arthritis drug was used by millions of people around the world.The company said it was withdrawing the drug following a review of data from a three-year colon cancer trial. In this study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in patients taking Rofecoxib compared to those taking placebo. Merck said the heart attacks and strokes were not spotted during the first 18 months of the trial but became apparent later.The colon cancer trial was designed to evaluate the effectiveness of the standard 25-milligram Rofecoxib dose in preventing recurrence of colon polyps. Such polyps sometimes become cancerous. Rofecoxib was used in the colon cancer trial because some researchers theorise that inflammation, present in arthritis, may be linked to colon cancer.

Worldwide sales of Rofecoxib totalled $2.55 billion last year. Since the introduction of the drug in 1999, 91 million Rofecoxib prescriptions have been written in the United States alone. The drug is sold in some countries under the name Ceoxx. Merck shares plunged 15 percent in pre-market trading after the announcement. Rofecoxib sales have been flat in recent years amid safety concerns. Clinical trial data have shown the drug increased the incidence of blood clots tied to strokes and heart attacks. A recent study by the U.S. Food and Drug Administration suggested patients taking Rofecoxib faced a 50 per cent greater risk of heart attacks and sudden cardiac death.

Patients who are currently taking Rofecoxib should contact their health care providers to discuss discontinuing use of Vioxx and possible alternative treatments.

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