On September 30, 2004, Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib) from the U.S. and worldwide markets due to safety concerns of increased risks for heart attacks, chest pains, blood clots, strokes, and sudden death for patients taking Vioxx.
Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by the FDA in May 1999 for the relief of osteoarthritis, for menstrual symptoms, and the management of acute pain in adults. Vioxx was later approved for the relief of painful symptoms of rheumatoid arthritis in children and adults.
Merck's action is the direct result of a clinical trial comparing Vioxx to sugar pills. The trial's main goal was to determine whether Vioxx could prevent recurrent colon polyps; however, the secondary goal was to observe Vioxx’s long-term safety.
Merck contacted the FDA on September 27, 2004, to request a meeting and to notify them that the Vioxx colon polyps and long term study had been halted. The next day Merck met with the FDA about their decision to voluntarily remove Vioxx from the market.
Vioxx is one of the most widely used drugs ever to be instantly removed from pharmacy shelves. Worldwide, two million people took Vioxx. In 2003, Vioxx earned $2.5 billion in sales. After the announcement, Merck's stock dropped by more than 25 percent in heavy trading.
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