Merck withdraws Vioxx

Merck &. Co.has voluntarily withdrawn worldwide Vioxx (rofecoxib), its arthritis and acute pain medication.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 trial, 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. 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 the patients taking Vioxx compared with 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 labeling for Vioxx.

'We are taking this action because we believe it best serves the interests of patients,' said Raymond Gilmartin, chairman, president and chief executive officer 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.'

About Vioxx

Vioxx was launched in the United States in 1999 and has been marketed in more than 80 countries. In some countries, the product is marketed under the trademark Ceoxx. Worldwide sales of Vioxx in 2003 were $2.5bn. Results of the VIGOR (Vioxx Gastrointestinal Outcomes Research) study, released in March 2000, demonstrated that the risk of gastrointestinal toxicity with Vioxx was less than with naproxen, but indicated an increased risk of cardiovascular events versus naproxen. However, in other studies including Merck's Phase III studies that were the basis of regulatory approval of the product, there was not an increased risk of cardiovascular events with Vioxx compared with placebo or Vioxx compared with other non-naproxen non-steroidal anti-inflammatory drugs (NSAIDs). Merck began long-term randomised clinical trials to provide an even more comprehensive picture of the cardiovascular safety profile of Vioxx. "Merck has always believed that prospective, randomised, controlled clinical trials are the best way to evaluate the safety of medicines. APPROVe is precisely this type of study - and it has provided us with new data on the cardiovascular profile of Vioxx," said Dr Peter Kim, president of Merck Research Laboratories. "While the cause of these results is uncertain at this time, they suggest an increased risk of confirmed cardiovascular events beginning after 18 months of continuous therapy. While we recognise that Vioxx benefited many patients, we believe this action is appropriate."