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At the time of its withdrawal, rofecoxib was the only coxib approved in the United States with clinical evidence of its superior gastrointestinal adverse effect profile over conventional NSAIDs. This was largely based on the VIGOR (Vioxx GI Outcomes Research) study, which compared the efficacy and adverse effect profiles of rofecoxib and naproxen.
A statistically significant increase in the incidence of myocardial infarctions was observed in patients on rofecoxib. Further data, from the APPROVe trial, showed a statistically significant relative risk of cardiovascular events of 1.97 versus placebo [60] —which caused a worldwide withdrawal of rofecoxib in October 2004. [61]
Where risks or harms is the reason for withdrawal, this will usually have been prompted by unexpected adverse effects that were not detected during Phase III clinical trials, i.e. they were only made apparent from postmarketing surveillance data collected from the wider community over longer periods of time.
The VIGOR trial results were published in 2000 in the New England Journal of Medicine [47] Bombardier and her research team claimed that there was "an increase in myocardial infarction in the patients given rofecoxib (0.4%) compared with those given naproxen (0.1%)" and "patients given naproxen experienced 121 side effects compared with 56 in ...
Valdecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms. It is a selective cyclooxygenase-2 inhibitor.
A category for drugs withdrawn from the market after marketing commenced for any reason (voluntarily or involuntarily). For drug candidates that were abandoned prior to being marketed due to side effects, lack of efficacy, superior competitors, or other reasons, see Category:Abandoned drugs
When looking at the results of the study, it showed a statistically significant increase in cardiovascular risk when taking rofecoxib compared to placebo [25] [26] beginning after 18 months of treatment. [25] [26] [27] Then on 30 September Merck gave out a news release announcing their voluntary worldwide withdrawal of Vioxx. [27]
His work showing that selective COX-2 inhibitors depress the production of prostacyclin in the endothelium, thereby increasing cardiovascular risk, [9] was instrumental in the withdrawal of Vioxx (rofecoxib) from the U.S. market in 2004. [4] [10]