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Avandia safety under assessment again

For the second time in three years, GSK's diabetes drug Avandia (rosiglitazone) is under FDA investigation over safety concerns

GlaxoSmithKline's (GSK) type 2 diabetes treatment Avandia (rosiglitazone) is again under investigation over concerns about its cardiovascular safety. The drug is being assessed by the US Food and Drug Administration (FDA) ahead of a separate investigation by the European Medicines Agency (EMA).

An initial FDA safety investigation was conducted in 2007 after a study claimed the drug increased the risk of heart attacks by 43 per cent.

At the time, the panel voted 22-1 to keep the drug on the market, but early in 2010, a report published by US senators again claimed a link between use of Avandia and risk of cardiovascular disease. The highly critical report was followed by two others, which also asserted that the drug carried significant risks.

GSK maintains that the drug, which now represents less than 3 per cent of its annual revenue, is safe and does not increase the incidence of cardiovascular disease, citing as support six controlled clinical studies that have been conducted since the initial safety investigation in 2007.

GSK last week sent a comprehensive review of the drug to the FDA, which countered that it judged GSK's results to be inaccurate. The conflicting scientific information about Avandia's safety has however led to key FDA figures being starkly divided over the issue, with Commissioner Margaret Hamburg believed to be anti-Avandia and chief of the drug division, Dr Janet Woodcock, in the pro camp.

The Daily Telegraph newspaper quoted RBS analyst Michael Leacock as writing: "Predicting which way the committee will vote is difficult. What is clear to us is that the resounding 22-1 vote from the last committee for Avandia to remain on the market is very unlikely to be repeated."

According to Dr Woodcock, drug withdrawal decisions are often complicated by the lack of "definitive proof" of risk with drugs that show "signals" of serious problems. Nevertheless, in the US, GSK is currently the subject of numerous federal and state lawsuits relating to Avandia, approximately 700 of which it has settled in recent weeks.

The current two-day meeting of the advisory panel will, at its conclusion, recommend one of three options: that Avandia remain on the market, that Avandia remain on the market with substantially increased safety warnings or that Avandia be withdrawn from the market.

Those speaking in front of the panel include Avandia critic Dr Steve Nissen and GSK vice-president for clinical development Dr Murray Stewart.

12th July 2010

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