US reviewers urge Glaxo's Avandia come off market

Two US drug safety reviewers have recommended that GlaxoSmithKline PLC's diabetes drug Avandia be pulled from the market after concluding it is more dangerous to the heart than a rival medicine, according to documents released on Saturday. Senators Max Baucus and Charles Grassley meanwhile released a report saying evidence suggested Glaxo knew of possible cardiac risks associated with Avandia years before the issue became public. In an October 2008 memo released by the senators, FDA reviewers David Graham and Kate Gelperin concluded "the risks of (Avandia) are serious and exceed those for" Takeda Pharmaceutical Co's competitor Actos. They said there was "strong evidence that (Avandia) confers an increased risk of" heart attack and heart failure when compared to Actos. They estimated that 500 more heart attacks and 300 cases of heart failure were occuring every month with use of Avandia instead of Actos, based on levels of use at the time of their memo. Sales of Avandia, known generically as rosiglitazone, topped $3bn in 2006 but fell to $1.2bn in 2009.