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 (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 US labeling for VIOXX.

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 of action.

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 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.

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. 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. 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.

Merck has informed the FDA of its decision. Customers should stop distribution and no longer dispense VIOXX. Patients who are currently taking VIOXX should contact their health care providers to discuss discontinuing use of VIOXX and possible alternative treatments.

National Notification Center (NNC), an independent company contracted by Merck, will contact you within 3 to 5 business days with instructions on how to return undispensed product and receive appropriate credit. If a patient asks the pharmacist about returning unused VIOXX, please advise the patient that Merck will reimburse them for the cost of unused product. Instructions for patient reimbursement are attached and are posted at www.vioxx.com or can be obtained by calling NNC directly at 1-800-805-9542.

Patients and health care professionals may obtain information from www.merck.com and www.vioxx.com, or may call 1-888-36-VIOXX (1-888-368-4699).

The Prescribing Information for VIOXX accompanies this letter.

Sincerely,

William F. Keane, MD
Vice President
US Medical and Scientific Affairs

These instructions are specifically for patients. Other customers, such as Pharmacies and Wholesalers/Distributors, will receive separate instructions on how to return product and receive credit.

Instructions for patients on how to receive 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. Patients who call that number will receive a patient return kit directly from NNC which may be returned via UPS (United Parcel Service). The return kit includes a shipping container and a prepaid UPS shipping label, with complete instructions. Completed return kits can be placed into a UPS drop or delivered to a UPS drop-off location, or the patient can arrange for pick-up by calling UPS at 1-800-PICK-UPS. Refunds may take four to six weeks.

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