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Merck withdraws Vioxx based on 3-year data from APPROVe clinical trial

Published in Biotech Business Week, October 25th, 2004

Merck &. Co., Inc., announced the voluntary worldwide withdrawal of Vioxx (rofecoxib), its arthritis and acute pain medication, based on new, 3-year data from a prospective, randomized, 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...

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