 |
|
|
|
 |
|
||
 |
RecallDrugs.com Latest News | Product Info | Patient Info | FDA | Links | Latest Lawsuit Info Home | Why Drugs Get Recalled | Buying Drugs Online | Drugs To Watch To assist Vioxx patients with the recall, Merck has released the following information: Information For Patients Frequently Asked Questions Refund Instructions Merck Press Release Sept. 30, 2004 
Important Information For People Taking VIOXX September 30, 2004 Merck Voluntarily Withdraws VIOXX Dear VIOXX Patient: Merck & Co., Inc. announced today a voluntary withdrawal of VIOXX®. This decision is based on new data from a three-year clinical study. In this study, there was an increased risk for cardiovascular (CV) events, such as heart attack and stroke, in patients taking VIOXX 25 mg compared to those taking placebo (sugar pill). While the incidence of CV events was low, there was an increased risk beginning after 18 months of treatment. The cause of the clinical study result is uncertain, but our commitment to our patients is clear. 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 merck.com and vioxx.com or may call 1-888-368-4699. Merck will reimburse all patients for their unused VIOXX. All dosage strengths and formulations of VIOXX are affected by this voluntary withdrawal. Information can be found at vioxx.com or at 1-888-368-4699. Merck is notifying physicians and pharmacists and has informed the Food and Drug Administration of this decision. We are taking this action because we believe it best serves the interests of patients. That is why we undertook this clinical trial to better understand the safety profile of VIOXX. And it’s why we instituted this voluntary withdrawal upon learning about these data. Be assured that Merck will continue to do everything we can to maintain the safety of our medicines. Raymond V. Gilmartin, Chairman, President & CEO Frequently Asked Questions for Patients Why is Merck withdrawing VIOXX? Merck & Co., Inc., is voluntarily withdrawing VIOXX® (rofecoxib) effective immediately based on new data from a 3-year clinical study. In this study, there was an increased risk for cardiovascular (CV) events, such as heart attack and stroke, in the patients taking VIOXX 25 mg compared to those taking placebo (sugar pill). There was an increased risk beginning after 18 months of treatment. What should I do if I’ve been taking VIOXX? Patients who are currently taking VIOXX should contact their healthcare providers to discuss discontinuing use of VIOXX and possible alternative treatments. What should I do with my VIOXX tablets? Merck will reimburse patients for unused VIOXX tablets. You should retain your tablets. Reimbursement information is posted on this website. Will the company reimburse me for unused VIOXX? Yes. Merck will reimburse patients for unused VIOXX tablets. How do I get reimbursement for unused VIOXX? Information on what patients need to do for reimbursement is posted on this website. What do I do if I have more questions about VIOXX? Contact your healthcare provider to discuss questions you have about VIOXX and to discuss your medical condition. How to receive a refund for unused VIOXX Merck will reimburse patients for unused VIOXX® (rofecoxib). Merck is offering patients a full refund for the amount they paid out-of-pocket for VIOXX prescriptions that remained unused as of September 30, 2004. Patients seeking a refund for unused VIOXX should contact the National Notification Center (NNC) at 1-800-805-9542. Refunds may take four to six weeks. Merck Announces Voluntary Worldwide Withdrawal of Vioxx® WHITEHOUSE STATION, N.J., Sept. 30, 2004---Merck & Co., Inc. 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 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," said Raymond V. Gilmartin, chairman, president and chief executive officer of Merck. "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." APPROVe was a multi-center, randomized, placebo-controlled, double-blind study to determine the effect of 156 weeks (three years) of treatment with VIOXX on the recurrence of neoplastic polyps of the large bowel in patients with a history of colorectal adenoma. The trial enrolled 2,600 patients and compared VIOXX 25 mg to placebo. The trial began enrollment in 2000. 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. Results of the VIGOR (VIOXX Gastrointestinal Outcomes Research) study, released in March 2000, demonstrated that the risk of gastrointestinal toxicity with VIOXX was less than with naproxen, but indicated an increased risk of cardiovascular events versus naproxen. However, in other studies including Merck’s Phase III studies that were the basis of regulatory approval of the product, there was not an increased risk of cardiovascular events with VIOXX compared with placebo or VIOXX compared with other non-naproxen non-steroidal anti-inflammatory drugs (NSAIDs). Merck 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 Peter S. Kim, Ph.D., president of Merck Research Laboratories. "While the cause of these results is uncertain at this time, they suggest an increased risk of confirmed cardiovascular events beginning after 18 months of continuous therapy. While we recognize that VIOXX benefited many patients, we believe this action is appropriate." 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. Patients who are currently taking VIOXX should contact their health care providers to discuss discontinuing use of VIOXX and possible alternative treatments.
|
 |
|
 |
 |
 |
|
 |
 |
|
|