Rosiglitazone (Avandia, Avandamet)

This safety message has been superseded by a message issued on 26 July 2010

Rosiglitazone (Avandia, Avandamet) is an effective treatment for patients with type 2 (ie non-insulin-dependent) diabetes and belongs to a class of drugs called thiazolidinediones (also called glitazones).

Concerns about the cardiovascular safety of rosiglitazone led to a Europe-wide review of all available safety data, including cardiovascular safety data from clinical trials, that was completed in 2007 and concluded that the balance of risks and benefits of rosiglitazone remain favourable in its licensed indications.

This review led to updated prescribing information that included additional warnings that rosiglitazone should be used in patients with ischaemic heart disease only after careful evaluation of every patient’s individual risk.

Furthermore, rosiglitazone combined with insulin should be used only in exceptional cases and under close supervision.

Patients are advised to continue with their treatment. However, if they have any concerns they should discuss these with their doctor at their next routine appointment.

The MHRA and European Medicines Agency (EMA) work together to continuously monitor the safety and quality of medicines after they have been licensed so that swift and appropriate action can be taken to protect patients, should the need arise.

They also look at any new data that comes to light about a medicine and can update the product information if necessary.

Further information about the safety of rosiglitazone and other medicines in this class can be found on the MHRA website.