GlaxoSmithKline to revise labelling for Avandia after EU regulator's decision

- CNN

01/24/2008 -  GlaxoSmithKline (NYSE:GSK) PLC said is to revise the labelling on its Avandia diabetes product to include additional warnings that the product may be associated with an increased risk of heart attacks, after a decision by the European regulator (CHMP) today.

GSK said that the guidance will also state that the risk had not been confirmed in three separate clinical trials and that the overall data on heart attacks is inconclusive.

The warnings will state that the product should not be prescribed to patients with diagnosed heart disease or artery problems.

The FDA's 'black box' warning for Avandia has affected sales significantly in the US, with a fall of at least 30 pct during 2007.

Mike Ward at Nomura Code Securities said the decision had been widely expected with EU regulators bringing the product's safety information inline with those in the US.

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