Avandia® gets new labelling in Europe warning of increased heart problems for users

Following an evaluation of the thiazolidinedione class by the European Medicines Agency, GlaxoSmithKline has (GSK) announced (Press release) that it will revise the EU label for its type 2 diabetes drug, Avandia a common and popular alternative for patients who cannot take metformin. This will state that available data suggest that the compound may be associated with an increased risk of myocardial ischaemic events.

GSK specified that the labelling changes will be made to all products containing the main ingredient in Avandia® (rosiglitazone maleate) and Avandamet ® (rosiglitazone maleate and metformin hydrochloride) and Avaglim ® (rosiglitazone maleate and glimepiride).

The labelling will be modified to specify that the drug is contraindicated in patients with acute coronary syndrome, and that use of Avandia is not recommended for patients with ischaemic heart disease or peripheral arterial disease.

GSK however note that the increased myocardial ischaemic risk “was not confirmed or excluded in three long-term clinical trials and the data in their entirety on myocardial ischaemia are inconclusive.”

“The EMEA has previously concluded that the benefits of rosiglitazone continue to outweigh its risks. The revisions to the rosiglitazone label resulting from this review will provide some additional guidance to physicians prescribing rosiglitazone,” said Dr Alastair Benbow, Vice President and European Medical Director, GSK.

Labelling requirements were updated by the FDA in the US over cardiovascular concerns on November 14th 2007 "FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia " , so this brings the EU label in line with the US product labelling.

This need for re-labelling follows a "meta-analysis" published by Dr. Steven Nissen, chief cardiologist for the Cleveland Clinic, in the New England Journal of Medicine in May 2007 which detailed a major study showing increased risks of heart attacks, especially amongst Diabetes Type II patients without other signs or indicators of heart problems. Previous post here