Months after Sanofi-Aventis yanked its Phase IIIb PALLAS trial studying dronedarone (Multaq) due to an increase of cardiovascular event rates, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has recommended that the drug's use be restricted.
An FDA review showed that dronedarone increased death two-fold, and stroke and hospitalization three-fold, when compared with placebo. EMA urged that the anti-arrhythmic should only be prescribed for maintaining heart rhythm in patients with paroxysmal or persistent atrial fibrillation (AF) for sinus rhythm after a successful cardioversion procedure.
However, EMA also noted that the dronedarone should only be prescribed to patients after alternative treatment options have been considered. The agency’s conclusions are based off the increased risk of lung, liver and cardiovascular adverse events found.
Dronedarone was approved in 2009 for use in non-permanent fibrillation patients. EMA suggested that patients currently taking the drug consult their doctor about its risk.
Despite the committee recommending restricting use, the committee did say “the availability of a range of treatments for a difficult condition such as atrial fibrillation was important and that for some patients with non-permanent atrial fibrillation Multaq remains a useful treatment option.”
Therefore, the committee concluded that:
- Dronedarone be restricted to patients with paroxysmal or persistent AF. The drug is not indicated for use in patients when AF is present;
- Dronedarone should be started and monitored by a specialist only after other anti-arrhythmics have been considered;
- Dronedarone should not be prescribed in patients with permanent AF, heart failure or left ventricular systolic dysfunction;
- Dronedarone should not be prescribed in patients who have had previous liver or lung injury following treatment with amiodarone, or other anti-arrhythmics; and
- Patients on dronedarone should have lung and liver function monitored regularly.
The committee has forwarded its conclusions to the European Commission for decision.