Response to report in the New England Journal of Medicine regarding the use of rosiglitazone (AVANDIA) by people with type 2 diabetes

Source: Diabetes Australia

On 21st May 2007 the New England Journal of Medicine reported on a new analysis which highlighted the possibility of increased risk of heart attack (myocardial infarction and death from cardiovascular causes) through the use of rosiglitazone (AVANDIA) by people with type 2 diabetes.

Diabetes Australia is closely monitoring the situation. It is important to note that the report is based on a preliminary study, which by its design cannot be definitive. The authors of the recently published study themselves state that it has important limitations and the results have ‘considerable uncertainty about the magnitude of observed hazard’.

Diabetes management should be monitored and assessed on an individual basis through consultation between patient and doctor. However Diabetes Australia suggests that people with type 2 diabetes who take rosiglitazone (AVANDIA) should not stop using this medication until they have discussed their ongoing use of this medication individually with their GP or specialist. If a decision is then made to discontinue rosiglitazone (AVANDIA), alternative treatments to maintain diabetes control will need to be considered.

In Australia, we have a robust system whereby medications are approved and constantly reviewed by the Therapeutic Goods Administration (TGA).

The TGA carries out a range of assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard. This assessment and monitoring in turn protects the health and wellbeing of the Australian public.

Unless or until the TGA takes action in relation to the use of rosiglitazone (AVANDIA), Diabetes Australia’s recommendation is that people who are on this medication should discuss with their doctor whether it is appropriate for them to continue to take the medication by weighing up the risks and benefits.

Diabetes Australia advises that people with diabetes take this opportunity to discuss heart disease risks with their treating doctor.

A copy of the New England Journal of Medicine report can be seen on the Diabetes Australia website along with a statement issued by the TGA.