The following information is a summary about Vioxx. It is not intended to replace a doctor's instructions.
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. 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).
Instructions for Returning Unused Vioxx
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.
This information is also available on www.vioxx.com and www.merck.com
Instructions for patients on how to receive refund for unused VIOXX
Merck will reimburse patients for unused VIOXX® (rofecoxib).
Patients seeking a refund should return any unused VIOXX tablets and oral suspension via regular US mail to the following address:
NNC Group
Merck Returns
2670 Executive Drive
Indianapolis, IN 46241
1.800.805.9542
Patients must include the following information when returning any unused VIOXX tablets and oral suspension:
Name, address, and phone number
Unused product in its original pharmacy packaging
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 US mail.
What other Vioxx information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during treatment to check your response to Vioxx.
Do not let anyone else take your Vioxx medication. Ask your Vioxx pharmacist any questions you have about refilling your Vioxx prescription.
In case of Vioxx emergency/overdose
In case of Vioxx overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What should I do if I forget a Vioxx dose?
Take the missed Vioxx dose as soon as you remember it. However, if it is almost time for the next Vioxx dose, skip the missed Vioxx dose and continue your regular Vioxx dosing schedule. Do not take a double Vioxx dose to make up for a missed one.
Other uses for this Vioxx medicine
This Vioxx medication may be prescribed for other uses; ask your doctor or pharmacist for more Vioxx information.
What storage conditions are needed for Vioxx?
Keep Vioxx in the container it came in, tightly closed, and out of reach of children. Store Vioxx at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any Vioxx medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your Vioxx medication.
