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What does the TGA have to say about the Avandia controversy?

Further to the previous post, wrapping the latest international news on the diabetes drug Avandia with some reaction from Australian experts, here is a statement from a Therapeutic Goods Administration spokeswoman:

“Rosiglitazone (Avandia) is used for the treatment of Type 2 Diabetes Mellitus in patients inadequately controlled by diet and exercise, as monotherapy or in dual combination therapy with metformin or sulfonylureas.

The Australian Product Information includes a boxed warning stating that: “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 February 2010, the USA Senate Committee on Finance recently criticised the corporate conduct and ethics of Avandia’s sponsor, GlaxoSmithKline (GSK) on the basis that they allegedly did not provide timely information on the risks with its use.

There has been vigorous debate in the literature regarding the safety of this drug. The USA Food and Drug Administration is reviewing the protocol for a clinical trial (TIDE study) considering the safety of this drug and also undertaking a detailed individual patient analysis of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) study, a prospective randomised clinical trial.

The TGA has convened three meetings of a Rosiglitazone Expert Advisory Panel and also has referred the matter (most recently March 2010) to the Advisory Committee on Safety of  Medicines to advise on and assess the safety concerns.

In Australia the decision to date has been to retain registration but with restricted use and regulation of all promotional and educational activities. These changes and changes to the Pharmaceutical Benefits Scheme listing have seen the number of patients receiving rosiglitazone fall from at least 40,000 and growing, to perhaps 20,000 at most and falling.

The current product information accurately and adequately reflects the known safety of rosiglitazone, based on  clinical trials and post-marketing pharmacovigilance. However, it is always subject to review based on new evidence. The TGA is continuing to evaluate all available trial data and to monitor and analyse reports on the safety issues.

Rosiglitazone remains available on the Pharmaceutical Benefits Scheme through a streamlined authority mechanism. However given the warnings in the PI’s it is unlikely that many doctors would be prescribing Rosiglitazone to new patients, it is most likely to be used in patients already stabilised on the drug with ongoing monitoring for any cardiac signals.

The TGA is in close contact with the FDA and other Regulators internationally and will examine any new evidence that becomes available.”

***
Update, 16 July. GlaxoSmithKline Australia’s statement can be downloaded here.

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