The European Medicines Agency has recommended that the anti-arrhythmic, dronedarone (Multaq®), should be restricted.
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 data suggesting an increased risk of severe liver injury and lung effects.
The Committee for Medicinal Products for Human Use (CHMP) notes, however, that there are limited treatment options for patients with non-permanent atrial fibrillation, so dronedarone might still be a useful treatment option in selected patients. It says that: “the benefits of Multaq® outweigh its risks in these patients, provided that further changes to the information for prescribers and patients will be introduced to minimise the risk of injury to the liver, lung, and heart”.
It adds that dronedarone should be restricted to patients with paroxysmal or persistent atrial fibrillation when sinus rhythm is obtained and should not be used when atrial fibrillation is still present. It should not be used in permanent atrial fibrillation or in patients with heart failure or those with left ventricular systolic dysfunction. It should also not be used in patients with a previous lung or liver injury following treatment with amiodarone. Patients with non-permanent atrial fibrillation treated with dronedarone should be monitored by a specialist and have their lung, liver, and heart-rhythm function checked regularly.