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Wednesday, August 23, 2017
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Should Rofecoxib (Vioxx) Have Been Withdrawn Years Ago?

Henry I. Bussey, Pharm.D., FCCP, FAHA
November 2004

Review: Peter J√ľni, Linda Nartey, Stephan Reichenbach, Rebekka Sterchi, Paul A Dieppe, Matthias Egger. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004; 364, 9447.*

Swedish investigators conducted a meta analysis of 18 randomized controlled trials and 11 observational reports to conclude that data were adequate to warrant withdrawal of rofecoxib as early as 2000. Further, these investigators point out that FDA data often provide more thorough information than published studies, and they suggest that companies should perform continuous monitoring and evaluations of their products.

*The full text of this article is available for free on The Lancet's website, but you may have to register to view it. Registration is free.

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Wednesday, August 23, 2017