Arthritis drug Vioxx (Rofecoxib) has been voluntarily recalled by Merck & Co Inc. worldwide.
The move to pull the COX-2 inhibitor off the market on September 30, 2004 shocked the arthritis world and rocked the stock value of Merck.
The decision to recall Vioxx followed a three year trial, known as APPROVe (Adenomatous Polyp Prevention on Vioxx), which was a multi-center, randomized, placebo-controlled, double-blind study to determine the effect of Vioxx on the recurrence of neoplastic polyps of the large bowel in patients with a history of colorectal adenoma.
The trial which begain in 2000, involved 2,600 patients and compared Vioxx 25 mg. to placebo. The study revealed that an increased risk of cardiovascular complications began 18 months after patients started taking Vioxx.
Merck CEO Rymond Gilmartin said, “We are taking this action because we believe it best serves the interests of patients.” Vioxx, which was launched in the United States in 1999 for the treatment of arthritis has been marketed in 80 countries and used by 84 million people worldwide.
What Lies Ahead?
Acting FDA Commissioner Dr. Lester M. Crawford stated in a press release that the FDA will closely monitor other drugs in this class for similar side effects. Crawford added, “All of the NSAID drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician.”
There are existing lawsuits filed against Merck because of Vioxx and some analysts predict there will be more provoked by the recall. What will this mean for other COX-2 inhibitors? It is expected to impact them in some way. Will it cause a surge in the popularity and use of Celebrex (Celecoxib) and Bextra (Valdecoxib)? Will Novartis’ yet-to-be approved Prexige (Lumiracoxib) be affected? Even Merck has another COX-2 inhibitor, Arcoxia (Etoricoxib) , which has been highly-anticipated and expected to get FDA-approval soon.