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Rosiglitazone (brand name Avandia, Avandamet▼) and pioglitazone (brand name Actos, Competact▼) are treatments for patients with type 2 (i.e., non-insulin dependent) diabetes and belongs to a class of drugs known as thiazolidinediones (also called glitazones).
Concerns have arisen about the possibility of a small increased risk of myocardial infarction (heart attack) in patients treated with rosiglitazone. Patients with diabetes have an increased risk of cardiovascular disorders, including heart failure and ischaemic heart disease, because of their underlying condition. An association between rosiglitazone and pioglitazone and cardiac failure has been recognised since they were first licensed and the cardiovascular safety of these medicines is kept under continuous review. In October 2006, after a review of the available clinical trial data, product information for prescribers and patients was updated to reflect more fully the risk of heart failure and to include a warning about the potential small increased risk of myocardial infarction in patients receiving rosiglitazone compared with those receiving placebo (dummy pills).
Rosiglitazone (Avandia, Avandamet▼) and pioglitazone (Actos, Competact▼) are authorised through one of the European licensing procedures, the centralised procedure, and there has been a Europe wide review of the available data on the safety and efficacy of rosiglitazone and pioglitazone.This review has now concluded and the European Medicines Agency has issued a statement about the conclusions reached (see link below).
In this statement they advise that the review has concluded that the benefits of both rosiglitazone and pioglitazone in the treatment of type 2 diabetes continue to outweigh their risks. However, the prescribing information should be updated to include a warning that, in patients with ischaemic heart disease, rosiglitazone should only be used after careful evaluation of each patient’s individual risk. In addition, the combination of rosiglitazone and insulin should only be used in exceptional cases and under close supervision.
› EMEA press release: European Medicines Agency confirms positive benefit-risk balance for rosiglitazone and pioglitazone (external link)
