Because the drug increases the risk of liver, lung and cardiovascular adverse events, CHMP recommends that dronedarone should be used only after alternative treatments have been considered.
In its review, CHMP concluded that dronedarone increases the risk of injury to the liver and the lungs and may increase the risk of cardiovascular side effects in some patients with non-permanent AF.
The review was broadened in July when the PALLAS trial of dronedarone for the treatment of permanent AF was terminated early due to a significant increase in cardiovascular events in the dronedarone arm of the trial.