29.05.2007

Avandia diabetes drug concerns

On 21 May 2007, the New England Journal of Medicine published a study that has raised concerns about the possibility of a small increased risk of myocardial infarction (heart attack) and cardiovascular death in about 15 500 patients treated with rosiglitazone.

Rosiglitazone (brand name Avandia) is a treatment for patients with type 2 (i.e., non-insulin dependent) diabetes and belongs to a class of drugs known as thiazolidinediones (also called glitazones).

Patients with diabetes are at an increased risk of cardiovascular disorders, including heart failure and heart disease, due to the underlying condition. However, this drug may cause fluid retention, which in turn may make some heart problems worse or lead to heart failure. Warnings about this risk have been present in the product information since it was authorised in 2000.

In September 2006, following a comprehensive review, the product information for prescribers and patients was updated to reflect more fully the risk of heart failure and to include a warning about the potential small increased risk.

Avandia is authorised through one of the European licensing procedures, and the MHRA has issued a statement about the cardiac safety of rosiglitazone. In this statement they advise that patients should not stop treatment with rosiglitazone but should discuss their medication with their doctor at their next routine appointment.

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