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Irish Medicines Board Advisory Notice 
01/11/2010 
Irish Medicines Board issues Advisory Notice regarding ongoing benefit-risk review of anti-diabetes medicines containing rosiglitazone 

 

Following the publication (22 July 2010) of an advisory notice regarding the use of anti-diabetes medicines containing rosiglitazone, the Irish Medicines Board has consequently issued a Direct Healthcare Professional Communication (DHPC). This is accessible via the IMB website.

The DHPC re-emphasises the information previously published by the IMB and the European Medicines Agency and highlights the existing recommendations about the use of rosiglitazone (Avandia / Avandamet) in the treatment of diabetes. It also provides details of the review (currently taking place at EU level) of the new data concerning rosiglitazone and cardiovascular risk.

22 July 2010
The Irish Medicines Board (IMB) has issued an Advisory Notice regarding the European Medicines Agency (EMA) update on the ongoing benefit-risk review of rosiglitazone-containing medicines, Avandia, Avandamet and Avaglim.

The EMA is currently reviewing the impact of new data from recent publications on the risk of cardiovascular problems on the benefit-risk profile of these medicines.

Prescribers in the European Union are being reminded to strictly follow the current restrictions in the product information, pending further advice and recommendations.

Further details are available from the IMB website. In addition, the IMB will shortly publish a ‘Direct Healthcare Professional Communication’ on its website.