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Rofecoxib, more commonly known as Vioxx, was voluntarily withdrawn from the market by Merck on September 30, 2004. A widely accepted non-steroidal anti-inflammatory drug (NSAID), Vioxx was suspected by its producer to be related to several cardiovascular events, most commonly heart attacks and strokes, and other painful ailments.
Over its five year lifetime, Vioxx was prescribed to over 80 million people, and the year before it was removed from the market sales produced revenue of approximately $2.5 billion. It was one of the most lucrative drugs ever taken off the market by its manufacturer. Vioxx’s huge market success was a result of it aiding so many people in reducing or eliminating chronic or acute pain from osteoarthritis, dysmenorrhoea.
There is a lot of skepticism and controversy surrounding the release, studies, and eventual withdraw of Vioxx from the market. After its acceptance by the FDA as a “safe and effective” drug, later studies revealed that it may not actually be safe. The 12 month long Vioxx GI Outcomes Research (VIGOR) study materialized initial concerns about Vioxx and its relationship to cardiovascular problems. This study led to warning labels about Vioxx increasing the risk of heart attacks or strokes.
Any beliefs of openness and honesty that existed about Merck exposing possible risks were quickly halted when in just months after the first VIGOR study was published, more heart attacks caused by the drug were uncovered. The company’s rebuttal to the uncertainty of the accuracy of the study was that these additional heart attacks occurred after the predetermined time of the study had lapsed.