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VIOXX®
On September 30, 2004 the anti-arthritis drug VIOXX® was withdrawn from the market by its manufacturer Merck & Co. In announcing its decision to pull VIOXX® from the market, Merck disclosed that data from its APPROVe study (Adenomatous Polyp Prevention on VIOXX®) demonstrated an increased risk of cardiovascular events such as heart attack and stroke for patients using VIOXX® for 18 months or longer. According to Merck, the APPROVe study did not demonstrate a similar risk for short-term users. The study was designed to assess the efficacy of VIOXX® in preventing the recurrence of colorectal polyps in a defined patient population.
The withdrawal of VIOXX® from the market came shortly after the U.S. Food and Drug Administration approved the use of VIOXX® for children with juvenile rheumatoid arthritis on September 8, 2004.
While Merck has consistently denied that there is any valid association between VIOXX® and an increased risk of cardiovascular events, there has been mounting evidence to support such an association. Earlier this year, a retrospective study of approximately 1.4 million patients of a nationwide health insurer indicated that those taking more than 25mg of VIOXX® daily had a three-fold risk of cardiovascular events than those not taking it.
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