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The TGA is aware of recent regulatory decisions by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) regarding the status of rosglitazone (Avandia and Avandamet).
The TGA has already taken a number of significant steps to restrict the use of rosiglitazone and to preclude its use in patients at increased risk of adverse events, and the Australian approved Product Information (PI) in Australia is already more restrictive than in many overseas markets.
A Boxed Warning in the approved PI document states that rosiglitazone should not be used in patients with known ischaemic heart disease. The PI also clearly lists a number of important contraindications which include use in patients with heart failure, and in triple therapy.
The TGA has progressively reviewed the data on the safety of rosiglitazone as it has emerged and this has prompted the regulatory action already taken to date. While prescribing of the product has not been further restricted at this time and it has not been withdrawn from the market, the TGA's review of the safety of the product is ongoing.
The TGA is also carefully reviewing the decisions of the EMA and FDA as part of its consideration of whether further regulatory action is warranted in Australia.
The TGA wishes to reinforce to prescribers the importance of the advice contained in the approved PI. A copy of the Boxed Warning is reproduced below.
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.
Any patients currently taking Avandia or Avandamet who have concerns should discuss these with their treating practitioner.
A copy of the full PI may be obtained from the TGA eBS Product and Consumer Medicine Information site.