Vioxx Pulled From Global Market

Deborah Flapan

Disclosures

September 30, 2004

Sept. 30, 2004 — Merck & Co., Inc., announced today a voluntary withdrawal of rofecoxib (Vioxx) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events, according to an alert from MedWatch, the U.S. Food and Drug Administration (FDA) safety information and adverse event reporting program.

Rofecoxib is a cyclooxygenase 2–selective, nonsteroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms, and was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.

On Sept. 27, the data safety monitoring board for an ongoing long-term study of rofecoxib (APPROVe) recommended that the study be stopped early for safety reasons. The study showed an increased risk of cardiovascular events, including heart attack and stroke, in patients receiving rofecoxib compared with placebo, particularly those who had been taking the drug for longer than 18 months. Based on this new safety information, Merck and FDA officials met the next day, and during that meeting, the FDA was informed that Merck was voluntarily withdrawing rofecoxib from the market.

"Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," Acting FDA Commissioner Dr. Lester M. Crawford says in an FDA news release. "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."

According to an FDA public health advisory, patients who are currently taking rofecoxib should contact their physician for guidance regarding discontinuation and alternative therapies.  

Dr. Crawford added that the FDA will closely monitor other drugs in this class for similar adverse effects. "All of the NSAID[s] 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."

For more information, healthcare professionals are advised to contact Merck at 1-888-368-4699 or at http://www.merck.com, or the FDA's Drug Information Office at 1-301-827-4573 or 1-888-463-6332 or go to the FDA's Web site at: http://www.fda.gov/cder/drug/infopage/vioxx/default.htm.

Reviewed by Gary D. Vogin, MD

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