Merck Sharp & Dohme (MSD) Announces 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. “We are taking this action because we believe it best serves the interests of patients,” said Raymond Gilmartin, Chairman, President and Chief Executive Office of Merck & Co., Inc., Whitehouse Station, NJ, USA. “Although we believe it may 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 these data, we concluded that a voluntary withdrawal is the responsible course to take.” APPROVe was a multi-center, randomized, placebo-controlled, double blind study to determine the effect of 156 weeks (3 years) of treatment with VIOXX on the recurrence of a neoplastic polyps of the large bowel in patients with a history of colorectal adenoma. The trial enrolled 2600 patients, and compared VIOXX 25 mg to placebo. The trial began enrollment in 2000. VIOXX was launched in the U.S. in 1999, and has been marketed in over 80 countries. In some countries, the product is marketed under the trademark CEOXX. Worldwide sales of VIOXX in 2003 were $2.5 billion. Results of the VIGOR (VIOXX GI Outcomes Research) study, released in March 2000, demonstrated that the risk of gastrointestinal (GI) toxicity with VIOXX was less than with naproxen, but indicated an increased risk of cardiovascular events versus naproxen. However, in other studies including our Phase III studies that were the basis of regulatory approval of the product, there was not an increased risk of CV events on VIOXX compared with placebo or VIOXX compared with other non-naproxen NSAIDS.
Given MSD’s commitment to providing additional data that advance scientific knowledge about all of our medicines, MSD began long-term randomized clinical trials to provide an even more comprehensive picture of the cardiovascular safety profile of VIOXX. “Merck has always believed that prospective, randomized, controlled clinical trials are the best way to evaluate the safety of medicines. APPROVe is precisely this type of study--and it has provided us with new data on the cardiovascular profile of VIOXX,” said Dr. Peter S. Kim, President, Merck Research Laboratories. “While the cause of these results is uncertain at this time, they suggest an increased risk of confirmed CV events beginning after eighteen months of continuous therapy. While we recognize that VIOXX benefited many patients, we believe this action is appropriate.” 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, health care professionals may obtain information from www.merck.com and www.vioxx.ae. The results of clinical studies with one molecule in a given class are not necessarily applicable to others in the class. Therefore, the clinical significance of the APPROVe trial, if any, for the long term use of other drugs in this class, consisting of Cox-2 specific inhibitors and NSAIDs, is unknown. The Company will work with regulatory authorities in the 47 countries where ARCOXIA is approved to assess whether changes to the prescribing information for this class of drugs, including ARCOXIA, are warranted. MSD is continuing to seek approval for ARCOXIA in other countries, including the United States.
The Prescribing Information for VIOXX accompanies this letter.
Francois Chazelle Medical Director, Middle East & Africa Alise Reicin, MD Vice President, Clinical Immunology and Arthritis Research
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Given MSD’s commitment to providing additional data that advance scientific knowledge about all of our medicines, MSD began long-term randomized clinical trials to provide an even more comprehensive picture of the cardiovascular safety profile of VIOXX. “Merck has always believed that prospective, randomized, controlled clinical trials are the best way to evaluate the safety of medicines. APPROVe is precisely this type of study--and it has provided us with new data on the cardiovascular profile of VIOXX,” said Dr. Peter S. Kim, President, Merck Research Laboratories. “While the cause of these results is uncertain at this time, they suggest an increased risk of confirmed CV events beginning after eighteen months of continuous therapy. While we recognize that VIOXX benefited many patients, we believe this action is appropriate.” 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, health care professionals may obtain information from www.merck.com and www.vioxx.ae. The results of clinical studies with one molecule in a given class are not necessarily applicable to others in the class. Therefore, the clinical significance of the APPROVe trial, if any, for the long term use of other drugs in this class, consisting of Cox-2 specific inhibitors and NSAIDs, is unknown. The Company will work with regulatory authorities in the 47 countries where ARCOXIA is approved to assess whether changes to the prescribing information for this class of drugs, including ARCOXIA, are warranted. MSD is continuing to seek approval for ARCOXIA in other countries, including the United States.
The Prescribing Information for VIOXX accompanies this letter.
Francois Chazelle