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Avandia label data revised in US

GlaxoSmithKline's diabetes drug Avandia is to have its label information revised in the US following recent regulatory restrictions

GlaxoSmithKline's (GSK) diabetes drug Avandia (rosiglitazone) is to have its label information revised in the US following recent regulatory restrictions.

Prescribing information and medication guides for all medicines that contain rosiglitazone will be updated with extra safety information and restrictions. Other affected medicines are GSK's Avandamet and Avandary.

The revisions follow the US Food and Drug Administration's (FDA) decision in September 2010 to place the marketing of Avandia in a restricted access programme, after the drug was linked to cardiovascular events. Marketing authorisation for the drug was suspended by the European Medicines Agency (EMA).

According to the FDA, product information has been updated to describe the risk of cardiovascular events. Labels will also state that rosiglitazone-containing drugs should only be used in patients who had already been prescribed the medicines before the restrictions were put in place, and in patients whose diabetes could not be controlled by other therapies and did not want to use pioglitazone-containing medicines.

Further to the label revisions, GSK is to establish a Risk Evaluation and Mitigation Strategy (REMS) programme to restrict the use of rosiglitazone. The FDA said it expects to approve the strategy by spring, 2011.

The FDA has also requested an independent re-evaluation of the cardiovascular safety study, RECORD, involving Avandia. GSK said it 'continues to work to meet the FDA's request'.

The FDA has futher information about the use of Avandia in the US.

8th February 2011

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