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Vioxx May Increase the Risk of Heart Attacks and Strokes

Arthritis Drug Vioxx Taken Off the Market as Unsafe

WASHINGTON, D.C. -- October 4, 2004 -- A major drug manufacturer, Merck, has withdrawn its painkiller Vioxx (rofecoxib) from the market because it may increase the risk of heart attacks and strokes (FDA News, September 30, 2004). Vioxx is a nonsteroidal anti-inflammatory drug (NSAID) that blocks the enzyme COX-2. The Food and Drug Administration (FDA) approved the drug in 1999 to relieve arthritis symptoms, severe pain in adults, and painful menstrual cycles.

Merck's decision to halt Vioxx sales is based on data from a long-term clinical trial to see if Vioxx could be effective in preventing new polyps from forming in colon cancer patients. The researchers stopped the study when they discovered that patients who took Vioxx had a greater risk of heart attacks and strokes that those who took a placebo (a sugar pill). The increased risk was particularly great in patients who had been taking Vioxx for more than 18 months.

Other COX-2 selective NSAIDs on the market are Celebrex (celecoxib) and Bextra (valdecoxib). Vioxx is also related to the nonselective NSAIDs, such as ibuprofen and naproxen. The FDA said that it will closely monitor drugs in the same category as Vioxx to determine whether they also can cause heart attacks and strokes (Washington Post, September 30, 2004).

The agency is advising patients taking Vioxx to consult with their physicians about discontinuing the drug and taking alternative medications. It also points out that, when taken over a long period of time, all NSAIDs have risks, including gastrointestinal (stomach) bleeding, liver toxicity, and kidney toxicity. Therefore, patients using NSAIDs for more than two weeks should be under the care of a physician.

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