European Medicines Agency publishes update on ongoing benefit-risk review of Multaq

Notice type: Advisory

Date: 21/07/2011

 

Product name or type:
Multaq (dronedarone)


Problem Or Issue:
The European Medicines Agency (EMA) is currently reviewing the benefits and risks of Multaq (dronedarone), since preliminary data from a clinical study (PALLAS) have shown an increased risk of cardiovascular side effects such as cardiovascular death, stroke and cardiovascular hospitalisation in patients with permanent atrial fibrillation. This review was initiated in January 2011 following reports of severe liver injury and the scope of the review has been extended to include new information from the PALLAS clinical study which has very recently become available. 

Pending finalisation of the current review, prescribers are reminded to closely adhere to the recommendations in the product information with respect to the indication, contraindications and warnings. 

Patients are advised not to stop their medication without consulting their doctor and should discuss any concerns regarding their treatment with their doctor. 

The outcome of the review is expected in September 2011.


Background Information Or Related Documents:
European Medicines Agency publishes update on ongoing benefit-risk review of Multaq Document


Further Information:
EMA Press Release 

IMB Drug Safety Newsletter (February 2011)


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