EMA Reviews Cardiovascular Risk of Multaq
The European Medicines Agency is reviewing the cardiovascular risk of the anti-arrhythmic medicine Multaq.
The European Medicines Agency is reviewing the cardiovascular risk of the anti-arrhythmic medicine Multaq (dronedarone), from Sanofi Aventis. This follows the company’s announcement on 7 July 2011 of its discontinuation of the PALLAS study, because of the occurrence of severe cardiovascular events in some patients taking Multaq.
In the PALLAS study Multaq was being investigated in patients over 65 years of age with permanent atrial fibrillation. The patient population being studied in the PALLAS study is different from the population for which Multaq is currently approved, which is patients who currently have or have had non-permanent atrial fibrillation.
The study was carried out as part of the ongoing development programme for Multaq. At the time the study was
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