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EMEA tightens up on rosiglitazone label


The EMEA is to strengthen labelling for GlaxoSmithKline’s antidiabetic drug Avandia® (rosiglitazone) to recommend against its use in patients with ischaemic heart disease and/or peripheral arterial disease.

The move also applies to the other drugs within the Avandia portfolio �” Avandamet® (rosiglitazone maleate/metformin) and Avaglim® (rosiglitazone maleate/glimepiride).

Following a meeting earlier this month, the committee also recommended adding a new contraindication to the label to say Avandia must not be used in patients with acute coronary syndrome, such as angina or some types of myocardial infarction, because the medicine has not been studied in controlled trials in this specific patient group.

The changes have been recommended in the wake of an overall safety reassessment of Avandia and of Eli Lilly/Takeda’s Actos® (pioglitazone), which concluded in October last year that the benefits of both medicines outweighed their risks but that product information for Avandia should be updated.

The EMEA’s advisory panel, the CHMP, is also re-examining its guidance on use of antidiabetic products in clinical investigation and plans to release the main points for revision in February.

In the USA, Avandia carries a “black box” warning which states that a meta-analysis of 42 clinical studies showed rosiglitazone to be associated with an increased risk of myocardial ischaemic events such as angina or myocardial infarction.

However, the warning also notes that three other studies have “not confirmed or excluded this risk” and “in their entirety, the available data on the risk of myocardial ischemia are inconclusive”.


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