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| This safety message has been superseded by a message issued on 23 September 2010 |
23 May 2007
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).
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.
Patients with diabetes are at an increased risk of cardiovascular disorders, including heart failure and ischaemic heart disease, due to the underlying condition. However, thiazolidinediones 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. Furthermore, the patient information leaflet advises about this potential risk, and patients who are at risk of heart failure should talk to their doctor before they start taking Avandia.
In September 2006, following a comprehensive review within Europe of the available data from clinical trials, 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 of myocardial infarction in patients receiving rosiglitazone compared with those receiving placebo (dummy pills). This European review considered data from most of the studies that were included in the paper published in the New England Journal of Medicine.
Avandia is authorised through one of the European licensing procedures, the centralised procedure, and the European Medicines Agency has issued a statement about the cardiac safety of rosiglitazone (see link below). 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.
