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FDA safety official again attacks Avandia safety - with new CV risk data in the elderly

This article was originally published in Scrip

Executive Summary

The US FDA drug safety official Dr David Graham, who was highly critical of Vioxx (rofecoxib) before it was taken off the market, is once again in the spotlight over GlaxoSmithKline's Avandia (rosiglitazone). A draft of a new, unpublished retrospective observational study he and colleagues have completed in 227,000 elderly new users of a thiazolidinedione has been circulating in the US, and Dr Graham claims it shows an increased risk of various cardiovascular problems with Avandia compared with Takeda's similar product Actos (pioglitazone).



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