| Merck & Co. announced it is withdrawing it arthritis drug Vioxx® from the market worldwide. 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 study was aimed at showing that Vioxx at a 25 milligram dose prevents recurrence of polyps in the colon and rectum. The trial was stopped after Merck discovered the higher heart risk compared to patients taking placebo. Data from the trial showed that an increased risk of heart attack and other cardiovascular complications began 18 months after patients started taking Vioxx®. What does this mean?
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 www.merck.com and www.vioxx.com, or may call (888) 36-VIOXX (1-888-368-4699).
What do I do with the unused Vioxx® I have?
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:
1. Name, Address and Phone number
2. Unused product in its original pharmacy packaging
3. Pharmacy receipt corresponding to returned product
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.
What are my alternatives?
- Traditional NSAIDs: such as ibuprofen, naproxen, diclofenac, nabumetone, or etodolac (diclofenac, nabumetone, and etodolac have relatively low incidences of GI side effects)
- Cox-2 alternatives: valdecoxib (Bextra®) and celecoxib (Celebrex®)
The U-M Prescription Drug Plan has responded to this information by moving Bextra ® to Tier 2. UM Employees may obtain either Bextra® or Celebrex® at a Tier 2 co-pay level. Generics continue to be your most cost effective alternative.
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