Painkiller Vioxx® Pulled from Market Alert

Sept 30, 2004 -- Merck & Co announced today that it was pulling its popular arthritis and pain drug Vioxx (rofecoxib) from the worldwide market after a clinical trial showed that the drug carried an increased risk for heart attacks and strokes.

The increased cardiovascular risk was discovered during a trial to evaluate the effect of Vioxx in preventing recurrence of colorectal polyps. After 18 months of treatment, the patients taking Vioxx were found to be at greater risk for heart attack and stroke compared with those taking a placebo. The trial is being stopped.

Vioxx is a COX-2 selective nonsteroidal antiinflammatory drug (NSAID). Other COX-2 selective NSAIDs on the market at this time are Celebrex (celecoxib) and Bextra (valdecoxib) NOTE: April 7, 2005, Pfizer agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the with the FDA. For more information, please read the FDA press release. . Vioxx is also related to the nonselective NSAIDs, such as ibuprofen and naproxen.

Comment: The FDA today stated: "The risk that an individual patient will suffer a heart attack or stroke related to Vioxx is very small. We encourage people taking Vioxx to contact their physician to discuss discontinuing use of Vioxx and alternative treatments. Any decision about which drug product to take to treat your symptoms should be made in consultation with your physician based on an assessment of your specific treatment needs."

The following is the public health advisory released today by the FDA and the press release today from Merck & Co.

Barbara K. Hecht, Ph.D.
Frederick Hecht, M.D.
Medical Editors, MedicineNet.com

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FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product

The Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a nonsteroidal antiinflammatory drug (NSAID) manufactured by Merck & Co. FDA today also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.

Merck is withdrawing Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo. The study was being done in patients at risk of developing recurrent colon polyps.

"Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," said Acting FDA Commissioner Dr. Lester M. Crawford. "Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo."

Dr. Crawford added that FDA will closely monitor other drugs in this class for similar side effects. "All of the NSAID drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician."



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