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European Medicines Agency issues interim update on ongoing benefit/risk review of rosiglitazone–containing medicines

Notice type: Advisory

Date: 22/07/2010

  

Product name or type:
Avandia, Avandamet and Avaglim

Authorisation Number:
Glaxo Smith Kline

Problem Or Issue:
The European Medicines Agency is currently reviewing 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. Prescribers in the European Union are reminded to strictly follow the current restrictions in the product information, pending further advice and recommendations.

Background Information Or Related Documents:

Rosiglitazone was first authorised 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. Use of rosiglitazone-containing medicines has been contra-indicated in patients with heart failure or a history of heart failure since its first authorisation. Since then, the use of these medicines has been closely monitored and further restrictions and warnings regarding their use in patients with cardiac problems have been introduced. 

A further review of rosiglitazone was initiated at EU level in July 2010 following publication of studies raising additional concerns regarding cardiovascular safety. 

As additional, new data have very recently become available, these data will also be assessed at EU level, together with all other available data on the benefits and risks of rosiglitazone to allow the finalisation of the current review by September 2010. 

Advice to Healthcare Professionals and Patients:

While the Committee for Medicinal Products for Human Use (CHMP) is reviewing all available evidence on rosiglitazone, the following advice has been issued to healthcare professionals:

  • If considering initiating therapy, it is essential to strictly follow the recommendations in the product information with respect to patients indicated for treatment, defined contraindications and warnings. 
  • Closely monitor patients in accordance with the recommendations in the product information. 

The Irish Medicines Board has also issued a Direct Healthcare Professional Communication (28 July 2010).

Advice to patients:

  • Patients who wish to have more information on the potential risks and benefits associated with their treatment may contact their doctor and should consult the package leaflet. 
  • Patients are advised not to stop their medication without consulting their doctor.

 

European Medicines Agency issues interim update on ongoing benefit/risk review of rosiglitazone–containing medicines Document

Further Information:
For more information go to the Agency’s Press Release (22 July 2010)

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