Sunday, February 05, 2006
Vioxx Background
Vioxx was approved by the U.S. Food and Drug Administration in May 1999. It is marketed as 12.5 mg, 25 mg and 50 mg tablets and as an oral suspension. It is also available in 73 other countries. Merck estimates that 13 and 24 million patients have been prescribed the drug in the U.S. and worldwide, respectively. U.S. Vioxx sales exceeded $2.5 billion in 2001.
Vioxx is classified as a nonsteroidal anti-inflammatory drug (NSAID or NANSAID) with anti-inflammatory, analgesic and antipyretic properties. As such, it is indicated for pain, dysmenorrhea, osteoarthritis and rheumatoid arthritis. The earlier marketed NSAID products (i.e., ibuprofen, naproxen, etc.) are approved for similar indications, but are associated with greater (in frequency and severity) gastrointestinal-related adverse medical events.
Merck's VIGOR trial (Vioxx GI Outcomes Research) looked at the effects of Vioxx on stomach ulcers and bleeding. Submitted to the FDA in June 2000, the study showed that patients taking Vioxx had fewer stomach ulcers than those taking naproxen, but had more heart attacks.
The results of the VIGOR study led to new safety labeling requirements in April, 2002, advising of the increased risk of heart attacks.
Merck began a new trial in 2000, the APPROVe (Adenomatous Polyp Prevention on Vioxx) trial, to see if a 25 mg dose of Vioxx was more effective at preventing the recurrence of colon polyps than was a placebo. This trial was stopped early because it showed there was an increased risk for serious cardiovascular events, such as heart attacks and strokes, when the drug was taken for 18 months.
Vioxx was voluntarily withdrawn from the market by Merck Sept. 30, 2004.
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