Merck & Co pulls $2.5 billion/year blockbuster drug Vioxx on safety fears

In a move that depressed the US stock market and drug shares in particular on September 30, when drug major Merck & Co announced the voluntary worldwide withdrawal of Vioxx (rofecoxib), its blockbuster arthritis and acute pain agent which achieved worldwide sales of $2.5 billion in 2003. The company's decision, which it said is effective immediately, is based on new data from a prospective, randomized, placebo-controlled clinical evaluation, the APPROVe (Adenomatous Polyp Prevention on Vioxx) trial.

The study, which is being stopped, was designed to evaluate the efficacy of Vioxx 25mg in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas. In this trial, 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 the drug compared to those given 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 the drug, the firm noted.

"We are taking this action because we believe it best serves the interests of patients," said Merck's chief executive, Raymond Gilmartin, who added: "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."