Just over a year after speeding with unprecedented haste into the European Society of Cardiology’s atrial fibrillation guidelines with a class 1 recommendation, the role of dronedarone (Multaq, Sanofi) in the treatment of AF will be reconsidered. Responding to an announcement last week from the European Medicines Agency (EMA), the ESC again announced that it would issue a focused update of the AF Guidelines to be published next year.
In last week’s statement, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended new restrictions on dronedarone (Multaq). CHMP said that dronedarone should only be used for maintaining sinus rhythm in patients with paroxysmal or persistent AF after successful cardioversion. CHMP said that it was recommending that dronedarone no longer be used in patients who still have AF.
Since the publication of the ESC guidelines last September, dronedarone has been the subject of concerns regarding several cases of severe liver injury and the early termination of the PALLAS trial due to an increase in cardiovascular events in patients with permanent AF treated with dronedarone.
Editor’s Note: This is an updated version of a story originally published on August 4, 2011 when the ESC first announced the focused update in response to the news about the early termination of the PALLAS trial.
Here is the latest press release from the ESC (September 28, 2011):
ESC comments EMA statement on dronedarone
The European Medicines Agency (EMA) has recommended a restricted use of dronedarone.
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.