Merck Withdraws Acute Pain Medication

As the result of a new study showing an increased risk of heart attack and stroke after 18 months of treatment with an arthritis and acute pain medication called rofecoxib (Vioxx, Ceoxx), Merck & Co. (Whitehouse Station, NJ, USA) has announced a voluntary worldwide withdrawal of the drug from the market.

The multicenter, randomized, placebo-controlled study was designed to evaluate the effects of three years' treatment with rofecoxib 25 mg in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas. The trial results for the first 18 months showed no increased risk of cardiovascular events, and were similar to the results of two studies described in the current U.S. labeling for the drug.

The drug was launched in 1999 and has been marketed in more than 80 countries. Merck has informed the U.S. Food and Drug Administration (FDA) and regulatory authorities in other countries of its decision. The company suggests that patients currently taking the medication should contact their healthcare provider to discuss discontinuing use of the drug and possible alternative treatments.

"We are taking this action because we believe it best serves the interests of patients,” said Raymond V. Gilmartin, chairman, president, and CEO of Merck. "Although we believe it would have been possible to continue to market Vioxx with labeling that would incorporate these new data, given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take.”




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