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Merck Sharp & Dohme (MSD) withdraws VIOXX

posted Nov 23, 2009, 7:35 PM by DERC 藥物教育資源中心

(Originally posted on 2004-10-12)

The following is an excerpt from MSD's press release about its voluntary worldwide withdrawal of VIOXX.

"MSD today announced a voluntary worldwide withdrawal of 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, 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 25mg 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 (CV) 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 CV events on VIOXX, and in this respect are similar to the results of two placebo-controlled studies described in the current labeling for VIOXX."

[...]

"MSD has informed the FDA and regulatory authorities in other countries of its decision. The Company is also in the process of notifying health care practitioners in the U.S. and other countries where VIOXX is marketed. Patients who are currently taking VIOXX should contact their health care providers to discuss discontinuing use of VIOXX and possible alternative treatments. In addition, patients and health care professionals may obtain information from http://www.merck.com/ and http://www.vioxx.com/ or they may call our local hotline +852 2835 9819."

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