On September 30, 2004 Merck Pharmaceuticals announced that it was voluntarily withdrawing Vioxx from the market because of recent safety concerns. Clinical studies have shown that Vioxx increases the risk of blood clots linked to strokes and heart attacks. Merck’s data safety monitoring board overseeing a long-term Vioxx study confirmed the increased risk of serious cardiovascular events and recommended a recall be issued.
Since its introduction in 1999, 91 million prescriptions have been written for Vioxx in the U.S. alone. In April 2002, the Food and Drug Administration (FDA) implemented Vioxx labeling changes after Merck submitted a safety study finding an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking Vioxx compared to naproxen. A recent FDA study also found patients taking Vioxx faced a 50% greater risk of heart attacks and sudden cardiac death compared to those taking Celebrex. Other studies have also suggested the increased risk of cardiovascular events for patients using Vioxx.
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