Europe’s drug regulator, the EMEA, is to strengthen labeling for GlaxoSmithKline’s antidiabetic drug Avandia (rosiglitazone) to recommend against its use in patients with ischemic heart disease and/or peripheral arterial disease.

The move also applies to the other drugs within the Avandia portfolio of products - namely Avandamet (rosiglitazone maleate/metformin) and Avaglim (rosiglitazone maleate/glimepiride).

Following its meeting earlier this month, the committee has also recommended a new contraindication be added 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 both Avandia and Eli Lilly/Takeda’s Actos (pioglitazone), which concluded in October last year in saying that the benefits of both medicines outweighed their risks but that the product information for Avandia should be updated.

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

In the USA, Avandia carries a so-called black box warning which states that “a meta-analysis of 42 clinical studies…showed Avandia (rosiglitazone) to be associated with an increased risk of myocardial ischemic 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”.