This announcement follows the review of the overall benefits and risks of dronedarone initiated in January 2011. EMA states that “on the basis of the evaluation of the currently available data, the Committee concluded that there was an increased risk of Multaq causing injury to the liver as well as the lungs when used in accordance with the currently approved prescribing information. The Committee also considered that the cardiovascular events shown in the population in the PALLAS study could mean an increased risk of cardiovascular side effects for some patients with non-permanent atrial fibrillation”.
EMA considers that “for some patients with non-permanent atrial fibrillation, Multaq remains a useful treatment option.”
The European Society of Cardiology, as announced in a statement on 4 August 2011, is studying the latest information on dronedarone closely and will produce a focused update of its AF Guidelines next year. The ESC has already advised patients currently taking dronedarone to take advice from their physicians should they have any questions about their treatment.
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Notes to editor
3 previous ESC statements on dronedarone: