2.3. Anti-arrhythmic drugs
2.3.2. Drugs for arrhythmias
Restrictions:
Restricted to patients for the prevention of recurrence of AF in patients in whom beta-blockers, class 1c drugs and amiodarone are contraindicated, ineffective or not tolerated and who do not have a diagnosis of heart failure.
Prescribing Notes:
In accordance with the marketing authorisation and BNF, dronedarone should only be initiated and monitored only under specialist supervision. In cases where GPs continue the prescribing, associated monitoring should continue to be the responsibility of the acute sector.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended restricting the use of dronedarone (Multaq®) for maintaining heart rhythm in patients with paroxysmal or persistent atrial fibrillation for the maintenance of sinus rhythm after successful cardioversion. It has also recommended that due to an increased risk of liver, lung and cardiovascular adverse events, dronedarone should only be prescribed after alternative treatment options have been considered. The Committee also recommended a number of other risk minimisation measures to reduce the risk of injuries to liver, lung and cardiovascular system. Patients who are currently taking dronedarone are recommended to have their treatment evaluated by their doctor at their next scheduled appointment.