The Agency has stated that because of the increased risk of liver, lung, and cardiovascular adverse events, dronedarone, should only be prescribed after alternative treatment options have been considered. It advises that patients currently taking dronedarone should have their treatment reassessed by their physician at their next scheduled visit.
Dronedarone is currently approved for the treatment of paroxysmal or persistent atrial fibrillation or atrial flutter. The restriction is based on a review of the PALLAS trial, which was stopped early because of an increased risk of cardiovascular events among patients on dronedarone, as well as other
