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news.GlaxoSmithKline has announced that it will revise its European label for Avandia. The EMEA's Committee for Medicinal Products for Human Use has completed a positive benefit risk review of the thiazolidinediones including rosiglitazone in October 2007 and these label amendments are the result of this process.
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The label will be revised to state that available data indicate that rosiglitazone may be associated with an increased risk of myocardial ischaemic events. It will also state that this risk was not confirmed or excluded in three long-term clinical trials and the data in their entirety on myocardial ischaemia are inconclusive. The revised label will state that as a precaution, the use of rosiglitazone is not recommended in these patients. This information will appear in the warnings and precautions section of the label.
The label changes will be applied to all approved rosiglitazone-containing products: Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate and metformin hydrochloride) and Avaglim (rosiglitazone maleate and glimepiride).
Alastair Benbow, vice president and medical director, GSK, Europe, said: “The revisions to the rosiglitazone label resulting from this review will provide some additional guidance to physicians prescribing rosiglitazone.”