Arthritis drug withdrawn

Merck &. Co., Inc. yesterday announced a voluntary worldwide withdrawal of VIOXX® (rofecoxib), its arthritis and acute pain medication.

The company's decision, which is effective immediately, is based on new, three-year data from a prospective, randomised, placebo-controlled clinical test, the APPROVe (Adenomatous Polyp Prevention on VIOXX) trial.

The trial, which is being stopped, was designed to evaluate the efficacy of VIOXX 25 mg in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas.

The study showed there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking VIOXX compared to those taking placebo.

The results for the first 18 months of the APPROVe study did not show any increased risk of confirmed cardiovascular events on VIOXX and in this respect are similar to the results of two placebo-controlled studies described in the current US labelling for VIOXX.

"We are taking this action because we believe it best serves the interests of patients," said Raymond V. Gilmartin, chairman, president and chief executive officer of Merck. "Although we believe it would have been possible to continue to market VIOXX with labelling 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."

APPROVe was a multi-centre, randomised, placebo-controlled, double-blind study to determine the effect of 156 weeks (three years) of treatment with VIOXX on the recurrence of neoplastic polyps of the large bowel in patients with a history of colorectal adenoma. The trial enrolled 2,600 patients and compared VIOXX 25 mg to placebo. The trial began enrollment in 2000.