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Rofecoxib

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Rofecoxib

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Drug Class:  Analgesic, Cox ll Inhibitor

Merck & Co., Inc. on September 30, 2004 announced a voluntary worldwide withdrawal of VIOXX^® (rofecoxib), its arthritis and acute pain medication. The company’s decision is based on a three-year data from a prospective, randomized, placebo-controlled clinical trial, the APPROVe (Adenomatous Polyp Prevention on VIOXX) trial.

The trial 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 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 U.S. labeling for VIOXX.

"We are taking this action because we believe it best serves the interests of patients," the chairman, president and chief executive officer of Merck, Raymond V. Gilmartin, said in a statement on the New Jersey company's Web site.

"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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