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VIOXX® About VIOXX® - VIOXX® History VIOXX® (rofecoxib), manufactured by Merck, was an extremely popular prescription arthritis and pain medication until Merck's voluntary market withdrawl of the drug in the fall of 2004. FDA Approval and Skyrocketing Sales In 1999, Merck received FDA approval for VIOXX® as a treatment for pain from osteoarthritis, acute pain in adults, and menstrual pain. VIOXX® quickly became a mega-drug, being prescribed to nearly 25 million people by 2000* and accounting for nearly $2.5 billion in sales in 2003. Much of the drug's explosive sales was attributed to Merck's aggressive consumer and physician advertising tactics. In 2002 alone, Merck spent more than $171 million to promote VIOXX®. VIGOR Safety Study and FDA Label Changes In June 2000, while studying the gastrointestinal effects of VIOXX® in a study called VIGOR (VIOXX® Gastrointestinal Outcomes Research), Merck researchers found that patients taking VIOXX® (rofecoxib) exhibited an increased risk of serious cardiovascular events (i.e., heart attacks and strokes). In September 2001, the FDA the FDA issued a warning to Merck for misrepresenting the safety of VIOXX® by downplaying the cardiovascular risks associated with the drug's use. Then in April 2002, under the direction of the FDA, Merck implemented labeling changes to include information about the increase in risk of cardiovascular events, including heart attack and stroke. APPROVe Trial & VIOXX®'s Market Withdrawl In 2004, while studying VIOXX®'s ability to decrease the risk of developing recurrent colon polyps (the APPROVe Trial), findings once again demonstrated an increased risk of serious heart attacks and strokes for patients on the drug. These findings, combined with findings from other recent research studies about VIOXX®'s cardiovascular safety, led Merck to voluntarily withdraw the drug from the market on September 30, 2004. If you or a loved one has suffered a heart attack, heart arrhythmia, stroke or sudden cardiac death while taking Vioxx® and have questions about your legal rights, fill out our free case evaluation form. * source: July 2000 Kaiser poll Choose the state where you live to locate a Vioxx lawyer near you. |
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