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Community Info Health News
 How To Reach Us: St. Louis Front Page Community News P.O. Box 1354 St. Louis, MO 63188 http://www.slfp.com Voice: 314-771-0200 Fax: 314-771-0300 To submit news, contact: editor@slfp.com  |
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Merck Announces Voluntary Worldwide Withdrawal of VIOXX® ST. LOUIS, (SLFP.com), September 30, 2004 - In a stunning announcement, Merck & Co. today announced a voluntary worldwide withdrawal of VIOXX®, 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 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. In an announcement, Raymond V. Gilmartin, chairman, president and chief executive officer of Merck, said, "We are taking this action because we believe it best serves the interests of patients. 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." VIOXX is approved in the United States for the relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis, management of acute pain in adults. VIOXX was launched in the United States in 1999 and has been marketed in more than 80 countries. In some countries, the product is marketed under the trademark CEOXX. Worldwide sales of VIOXX in 2003 were $2.5 billion. Merck has informed the U.S. Food and Drug Administration and regulatory authorities in other countries of its decision. The company also is in the process of notifying health care practitioners in the United States and other countries where VIOXX is marketed. In a statement from London, Professor Sir Alasdair Breckenridge, chairman of the Medicines and Healthcare products Regulatory Agency (MHRA), said "Patients taking Vioxx should contact their doctor by phone or at the next convenient appointment to arrange an alternative prescription. The Committee on Safety of Medicine has looked at this issue this morning and agreed that this message should be communicated widely to health professionals and patients without delay". MHRA noted that the safety of rofecoxib has been under continuous review since it was authorised in 1999. The product information contains warnings and precautions for patients with predisposing factors to heart attack and stroke. The Committee on Safety of Medicine has previously warned that rofecoxib lacks protection against heart attack and stroke. On September 8, Merck announced that VIOXX had received approval from the U.S. Food and Drug Administration (FDA) for the relief of the signs and symptoms of the most common forms of juvenile rheumatoid arthritis (JRA), a debilitating type of arthritis that can occur in toddlers to teenagers. The approval of VIOXX for the relief of the signs and symptoms of JRA follows the recent approval of VIOXX in March for the acute treatment of migraine in adults. Patients who are currently taking VIOXX should contact their health care providers to discuss discontinuing use of VIOXX and possible alternative treatments. Merck & Co., Inc., based in Whitehouse Station, N.J., is a global research-driven pharmaceutical products company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures. Archived Stories: Classroom Triggers for Asthma and Allergies Obesity is Not a Disease Memory Study Gives New Hope in the Fight Against Alzheimer's Eating Apples and Drinking Apple Juice Today May Protect Brain Health Tomorrow Chamber Study Shows Obesity Lawsuits Are No Diet Aid Summer Season Sizzles With Potential for Injuries Around the Home  The SLFP.com - Community Info is presented in conjunction with the St. Louis Front Page and Southwest Illinois News. The sites are owned and maintained by the Moore Design Group for the sole purpose of disseminating news and information about the Metropolitan St. Louis area. Text or graphics may not be copied, rewritten or distributed in any manner whatsoever without written permission. For more information, contact editor@slfp.com All rights reserved world wide © 1996 - 2008 Moore Design Group . |
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