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Vioxx was approved by the
FDA and launched in the United States in 1999. It
was marketed in over 80 countries.
Vioxx was used to reduce pain and inflammation caused by
osteoarthritis,
as well as acute pain in adults and menstrual pain. It was one of a new kind
of nonsteroidal anti-inflammatory drug (NSAID) approved by FDA.
Subsequently, the FDA approved Vioxx to treat the signs
and symptoms of rheumatoid arthritis in adults and children. Vioxx is the
only NSAID to have demonstrated a lower risk of undesirable side effects
such as gastrointestinal ulcers and bleeding.
Unfortunately, three-year data from a prospective, randomized,
placebo-controlled clinical trial showed increased relative risk for
confirmed cardiovascular events, such as heart attack and stroke, beginning
after 18 months of continuous treatment in the patients taking Vioxx
compared to those taking placebo. Merck's decision was to voluntarily recall
Vioxx and to reimburse anyone with unused medication.
Merck expects about 16,000 people to file legitimate
Vioxx law suits against the company. Wall Street analysts project that the
number of successful law suits will be significantly higher.
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