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    Merck voluntarily withdraws VIOXX® (rofecoxib) Merck announces withdrawal - Merck announced today the voluntary withdrawal of the popular COX-2 VIOXX® (rofecoxib), which is used by millions for treatment of arthritis and acute pain. The voluntary withdrawal of all strengths and dosage forms of VIOXX® by Merck is based on the APPROVe (Adenomatous Polyp Prevention on VIOXX®) trial. The three-year data regarding patients taking VIOXX® showed an increased risk of severe cardiovascular events such as heart attack and stroke when compared to patients taking placebo. These risks were realized after 18 months of VIOXX® treatment. This confirms similar findings of the VIGOR (VIOXX® Gastrointestinal Outcome Research) study released in March 2000 which also suggested an increased risk of cardiovascular events. The results of the study are specific to VIOXX® and may not be applicable to the other two COX-2 drugs currently on the market, Pfizer-manufactured Celebrex® (celecoxib) and Bextra® (valdecoxib). The FDA has announced plans to monitor this drug class for any side effects similar to the VIOXX® study. RxAmerica takes action - All of RxAmerica's clients are being notified of this withdrawal and advised on how to proceed via e-mail and through contact with their Account Managers. Clients are also being provided with the manufacturer's patient return instructions (see below) for communication to their members. RxAmerica will also be assisting clients in notifying members when requested. Patients should be advised not to stop taking their medication before speaking with their physician about the potential implications of doing so. RxAmerica has already programmed its claims adjudication system to prevent claims for VIOXX® from processing, and patients should be advised that depending on benefit design, other COX-2 medications may be available to them at a preferred copay. RxAmerica is developing plan-specific impact studies and will provide each client with this information in no less than two business days. Ensuring appropriate utilization - Please remember that RxAmerica has several programs already in place that help ensure proper utilization of COX-2 medications as well as other drug classes. RxAmerica's web-based prior authorization tool, RxApprover™, helps physicians select drugs covered by the patient's prescription drug plan. RxAmerica's RxRewards™ program is designed to promote the use of the most effective agents in key therapeutic classes. Both of these programs help improve the quality of healthcare for members and reduce potential client spending in popular drug categories. Patient return instructions - Merck will reimburse patients for unused VIOXX®. Patients seeking a refund should return any unused VIOXX® tablets and oral suspension via regular U.S. mail to the following address:
ATTN: NNC Dept.
Merck Order Fulfillment Center
1645 Satellite Blvd.
Duluth, GA 30097
Patients must include the following information when returning any unused VIOXX® tablets and oral suspension:
Patients will receive a full refund of the price paid as reflected on their pharmacy receipt, plus the cost of shipping via regular U.S. mail. Patients should not attempt to return their medication at retail pharmacy outlets. These patient return instructions can also be found at www.vioxx.com and www.merck.com. |
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