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National Collaborating Centre for Chronic Conditions (UK). Type 2 Diabetes: National Clinical Guideline for Management in Primary and Secondary Care (Update). London: Royal College of Physicians (UK); 2008. (NICE Clinical Guidelines, No. 66.)

The European Medicines Agency (EMA) and rosiglitazone

September 2010 update

In September 2010 the European Medicines Agency (EMA), the European Union (EU) body responsible for monitoring the safety of medicines, recommended the suspension of the marketing authorisation for rosiglitazone (Avandia, Avandamet and Avaglim) from GlaxoSmithKline. The EMA has concluded that the benefits of rosiglitazone no longer outweigh its risks and the marketing authorisation should be suspended across the EU.

The EMA has advised that patients who are currently taking rosiglitazone-containing medicines should make an appointment with their doctor at a convenient time to discuss suitable alternative treatments. Patients are advised not to stop their treatment without speaking to their doctor. NICE does not recommend the use of drugs without marketing authorisation. Therefore, as a result of the EMA’s decision, NICE has temporarily withdrawn its recommendations on the use of rosiglitazone in this guideline.

Copyright © 2008, Royal College of Physicians of London.

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Cover of Type 2 Diabetes
Type 2 Diabetes: National Clinical Guideline for Management in Primary and Secondary Care (Update).
NICE Clinical Guidelines, No. 66.
National Collaborating Centre for Chronic Conditions (UK).

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