EMA Currently Reviewing Benefit- Risk Profile Of Avandia

22nd Jul 2010 16:22

LONDON (Dow Jones)--European Medicines Agency, announced Thursday it is currently reviewing Avandia or rosiglitazone to determine the impact of new data, from recent publications on the risk of cardiovascular problems, on the benefit- risk profile of these medicines. MAIN FACTS: -Prescribers in the European Union are reminded to strictly follow the current restrictions in the product information. -Avandia was initially authorized in the European Union in July 2000 as second-line diabetes type-2 treatment to be used when other treatments have either failed or are unsuitable for a patient. -Avandia has been contra-indicated in patients with heart failure or a history of heart failure since its first authorization. -It was subsequently approved in combination with metformin as Avandamet and with glimepiride as Avaglim. -Since then, the use of these medicines has been further restricted several times by new warnings and contra-indications on their use in patients with heart problems. -The Committee noted that additional new data sets have become available very recently. -It will assess these data in depth together with all other available data on the benefits and risks of rosiglitazone to allow the finalization of the current review by September 2010. -By Zechariah Hemans, Dow Jones Newswires; 44-20-7842-9411; [email protected] (END) Dow Jones Newswires July 22, 2010 11:22 ET (15:22 GMT)