Revised: 26 June 2013

Publications

Questions and Answers on rosiglitazone (Avandia)

17 February 2011

1. What is rosiglitazone?

Rosiglitazone is a medicine used in the treatment of type 2 diabetes. It is available under the brand name Avandia.

Rosiglitazone belongs to the class "thiazolidinediones" (also called glitazones). These medicines work (through PPAR receptors) in fat, muscles and the liver to make the body more sensitive to insulin. This reduces the amount of glucose (sugar) in the blood.

2. Why did Medsafe and the Medicines Adverse Reactions Committee (MARC) review the benefits and risks of rosiglitazone treatment?

The benefits and risks of rosiglitazone-containing medicines were reviewed following the announcement of international regulatory action.

In September 2010, the European Medicines Agency announced that rosiglitazone-containing medicines were being suspended until the company could supply convincing data to identify a patient population in which the clinical benefits of rosiglitazone-containing medicines clearly outweigh the risks. At the same time, the US Food and Drug Administration announced significant restrictions on the use of rosiglitazone-containing medicines.

3. What data have Medsafe and the MARC reviewed?

Medsafe and the MARC have reviewed the results of meta-analyses, observational studies and randomised controlled trials (including the RECORD study).

Minutes of the Medicines Adverse Reactions Committee

4. Why has the MARC recommended suspension of rosiglitazone-containing medicines?

The MARC considered that there is enough evidence that rosiglitazone increases the risk of heart attacks (myocardial infarction), which means that the risks of taking rosiglitazone outweigh the benefits. The same risk does not apply to patients taking pioglitazone.

In view of the restrictions already in place on the use of rosiglitazone, the MARC did not consider that further restrictions would reduce the risk of adverse effects on the heart. The MARC therefore recommended to the Minister of Health that rosiglitazone-containing medicines should be suspended until such time as satisfactory evidence can be provided by the company to identify a population of patients for whom the benefits of rosiglitazone treatment outweigh the risks.

5. What should patients do if they are currently taking Avandia?

Patients should NOT stop taking Avandia, but should make an appointment to talk to their doctor about alternative treatments.

The suspension will not come into effect until 29 April 2011 to allow patients time to change treatment.