Dronedarone (Multaq▼): cardiovascular, hepatic and pulmonary adverse events – new restrictions and monitoring requirements

Following new evidence of cardiovascular, hepatic and pulmonary risk, a review of dronedarone has concluded that the benefits of treatment continue to outweigh the risks for the maintenance of sinus rhythm after successful cardioversion in a limited population of patients with paroxysmal or persistent atrial fibrillation; however, in light of safety concerns dronedarone should only be prescribed after other treatment options have been considered. To support safer use, patients should have their treatment reviewed at the next routine appointment to ensure that they remain eligible for dronedarone treatment according to the revised prescribing information, including new restrictions on use. Regular monitoring of cardiac, liver, and renal function during treatment is recommended