Merck & Co., Inc. announced September 30, 2004, a voluntary withdrawal of Vioxx from the U.S. market due to health concerns. Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by the Food and Drug Administration (FDA) in May 1999 for the relief of pain and inflammation related to osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain. Subsequently, the FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children. When it was approved, Vioxx was shown to lower the risk of gastrointestinal ulcers and bleeding than other NSAIDs (such as ibuprofen and naproxen).
Vioxx has been removed from the market in all countries because of the unnecessary health risks placed upon its users. Vioxx use has been associated with an increased incidence of blood clots that lead to heart attacks, stroke, cardiovascular injuries and other serious side effects. According to Merck, about 2 million people worldwide are currently taking Vioxx, and a total of 105 million people have taken it since it came on the market in 1999. Vioxx's link to an increased incidence of blood clots had been found in multiple Vioxx clinical studies.
As far back as June 2000, Merck submitted to FDA a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) that found an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking Vioxx compared to patients taking naproxen. In April 2002, after reviewing the results of the VIGOR study and other available data from controlled clinical trials, FDA implemented labeling changes to reflect the findings from the VIGOR study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke. The drug remained on the market, however, and no action was taken by Merck & Co., Inc.
Merck & Co., Inc. informed the FDA on September 27, 2004, that the Data Safety Monitoring Board for an ongoing long-term study of Vioxx (APPROVe) had recommended that the study be stopped early for safety reasons. The study was being conducted in patients at risk for developing recurrent colon polyps. The study showed an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx compared to placebo, particularly those who had been taking the drug for longer than 18 months. Patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo.
Vioxx was created by Merck and launched in the United States in 1999 and has been marketed in more than 80 countries worldwide. In some countries, the product is marketed under the trademark Ceoxx. Worldwide sales of Vioxx in 2003 were $2.55 billion. Since Vioxx was launched in 1999, 91 million prescriptions for the drug have been written in the United States alone. Worldwide sales are unknown. In the past few years, Vioxx sales have been flat amid safety concerns worried about the increased incidence of blood clots tied to strokes and heart attacks found in clinical studies. Nothing was done until the latest clinical study administered by Merck proved the increased chance of heart attack or stroke from using Vioxx, and only then did the company recall Vioxx worldwide, on September 30th, 2004.
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