Voluntary Withdrawal of Vioxx

Voluntary Withdrawal of Vioxx

Merck & Co., Inc. voluntarily withdrew Vioxx (rofecoxib) from the market, after a recent study indicated a high risk of cardiovascular events, including heart attack and stroke, associated with long-term use of the medication. Vioxx is a non-steroidal antiinflammatory drug (NSAID) used to relieve osteoarthritis and rheumatoid arthritis symptoms and used for the management of acute pain and for the treatment of menstrual symptoms.

The Food and Drug Administration (FDA) issued a statement to acknowledge the voluntary withdrawal of Vioxx and issued a public health advisory statement to advise patients who are currently taking Vioxx to consult with their physician to find an alternative medication. Click here to learn more*.

Merck withdrew Vioxx based on recommendations from the Data Safety Monitoring Board for an ongoing long-term study of Vioxx, called the APPROVe (Adenomatous Polyp Prevention on VIOXX) trial. The APPROVe study was evaluating the effect of long-term treatment with VIOXX in patients at high risk for developing recurrent colon polyps. However, the trial was stopped early due to the increase in cardiovascular events, including heart attack and stroke, in patients taking Vioxx, particularly those who had been taking the drug continuously for longer than 18 months.

In 2001, Cleveland Clinic Heart Center Drs. Mukherjee, Nissen, and Topol published an article in the Journal of the American Medical Association, raising concern about Vioxx. They reviewed the results of two large studies (over 8000 participants), and two smaller studies (approximately 1000 participants) published between 1998 and 2001 related to Cox-2 inhibitors, the class of drugs that includes Vioxx.

They found patients taking Vioxx had more than twice as many heart attacks and strokes as patients who took naproxen, a commonly used over-the-counter antiinflammatory drug with similar benefits. Based on these results, investigators recommended that physicians use caution when prescribing the coxib drugs celecoxib (Celebrex) and rofecoxib (Vioxx) for patients who have established coronary artery disease or patients who have a high risk of coronary obstruction. Due to some limitations in the study, they suggested further trials to evaluate Cox-2 inhibitor risk. Click here to learn more.

In 2002, the FDA made packaging label changes on Vioxx to include increased cardiovascular risk, and also recommended that Merck conduct more studies to evaluate the heart safety of these drugs. In August of this year, Dr. Topol and Dr. Falk, a Cleveland Clinic gastroenterologist, published an editorial in The Lancet*, encouraging further warnings and labeling regarding the cardiovascular effects of Cox-2 drugs.

In a recent editorial published by The New York Times, Dr. Topol said, "The risk of heart attack or stroke found in the Merck study, at 15 cases per 1,000 patients, may be greatly underestimated. Merck's trial did not include anyone with known heart disease -- patients who might be expected to have the highest risk" He added, " Vioxx has repeatedly carried a far greater risk of heart attack and stroke in comparison to the other Cox-2 inhibitors. Yet the manufacturers of Cox-2 inhibitor agents have not studied patients who already have heart disease. He added: “It would be premature to conclude that the other drugs still on the market, like Celebrex and Bextra, do or do not carry some risk of heart attack until sufficient testing is done.”

What should I do if I’m taking Vioxx?

The risk of suffering a heart attack or stroke related to Vioxx is very small. If you are currently taking Vioxx, contact your physician to discuss stopping Vioxx and beginning alternative treatments. If you have been prescribed Vioxx, do not stop or start any new medications without speaking to your physician first.

For More Information
More patient information from the FDA can be found at: http://www.fda.gov/cder/drug/infopage/vioxx/default.htm*

More information about Vioxx from Merck & Co., Inc can be found at: www.merck.com* and www.vioxx.com*, or 1-888-36VIOXX (1-888-368-4699)