Defective Drugs: Vioxx ~ OPOLAW Injury Blog

Thursday, January 29, 2009

Defective Drugs: Vioxx

Vioxx is used as a treatment for signs and symptoms of osteoarthritis, acute pain in adults, and painful menstrual cycles. Serious problems from stomach ulcers, such as bleeding, are well known complications in people treated with NSAIDs. Similar problems have occurred in people treated with Vioxx. Other adverse reactions can include liver damage. Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss of appetite, itching, yellow coloring of skin or eyes, "flu like" symptoms and dark urine. The Vioxx Gastrointestinal Outcomes Research (VIGOR) conducted a prospective randomized double blind one year study evaluating approximately 4000 patients on Vioxx 50 mg a day and approximately 4000 patients on the standard dose of naproxen (1000 mg a day), a non steroidal anti inflammatory drug (NSAID). The study found that there was a higher cumulative rate of serious cardiovascular thromboembolic adverse events (such as heart attacks, angina pectoris and peripheral vascular events) in the Vioxx group (1.8%) compared to the naproxen group (0.6%). Adjudicated serious cardiovascular events (confirmed by a blinded adjudication committee) included: sudden death; myocardial infarction; unstable angina; ischemic stroke; transient ischemic attack; peripheral venous; and arterial thromboses. After carefully reviewing the results of the VIGOR Study, the FDA agreed with the Arthritis Advisory Committee recommendations of February 8, 2001 that the label for Vioxx should include the gastrointestinal and cardiovascular information. The committee advised that the NSAID class warning regarding gastrointestinal adverse events should be modified, but not removed from the Vioxx label. This warning advises patients and their doctors about the risks of gastrointestinal ulcers, bleeding and perforation.
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