UPDATE ON AVANDIA (ROSIGLITAZONE MALEATE)
People with diabetes in Australia who are being treated with rosiglitazone may be concerned with recent media reports about decisions made by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) concerning rosiglitazone.
The EMA has decided to suspend use of the drug in European Union countries.
The FDA has decided to significantly restrict the use of the drug to patients who cannot control their diabetes on other medications.
Note – these decisions relate to the European Union and the USA, and not to Australia at this time.
In Australia, rosiglitazone is approved and marketed as the single drug (Avandia) and in combination therapy (Avandamet). The Therapeutic Goods Administration (TGA) will further consider the approval and use of rosiglitazone in Australia. The current TGA advice may be found at:
Australia has stringent requirements for drug safety and the product information for Avandia requires a boxed warning that states:
‘The use of AVANDIA is not recommended in patients with known ischaemic heart disease, particularly in those taking nitrates. AVANDIA has been shown to be associated with an increased risk of myocardial ischaemia (angina, infarction) in pooled short-term clinical studies compared to combined active/placebo control (2.00% versus 1.53%, respectively), particularly in those who needed several antidiabetic drugs or nitrates.’
It is estimated that around 15,000 Australians are currently being treated with Avandia.
Diabetes Australia, the Australian Diabetes Society (ADS) and the Australian Diabetes Educators Association (ADEA) urge patients not to make any changes to their medication use without first discussing their treatment with their doctor.
“Patients on Avandia should discuss its use with their doctor, and whether it would be appropriate to continue it or switch to an alternative medication” said President of ADS Associate Professor Wah Cheung “Injudicious cessation of diabetes medications may result in higher levels of blood glucose that can cause severe short term health problems and increase the risk of diabetes related complications in the long term.”
www.diabetessociety.com.au
Fiona McIver, acting President of the ADEA said
“Patients are at increased risk of diabetes related complications if diabetes is not able to be managed adequately. However, there are many treatment choices that can be considered in discussion with their health care provider.” www.adea.com.au
Diabetes Australia Acting CEO, Prof Greg Johnson reinforced the message stating
“Anyone who is taking Avandia and who is concerned should talk to their doctor or diabetes health professional first. The cardiovascular safety profile of Avandia is still an open question and regardless of the decisions on Avandia, there are a range of options available for people to manage their type 2 diabetes and all options should be discussed with their health care providers.” www.diabeteseaustralia.com.au
Statement on potential conflict of interest: Associate Professor Wah Cheung President (ADS) has previously received conference travel support from the producers of Avandia, GSK.