The Food and Drug Administration (FDA) has approved Multaq® (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation (AF) or atrial flutter (AFL). AF and AFL cause the heart to beat abnormally fast and sometimes prevent blood from being properly pumped out of the heart. Multaq is approved for patients whose hearts have returned to normal rhythm on their own or who will undergo drug or cardioconversion therapy to restore a normal heartbeat.
AF/AFL can affect both men and women and becomes more common with increasing age. Causes can include alcohol use, congestive heart failure, coronary heart disease, heart surgery, hypertension, and hyperthyroidism.
Multaq may cause critical adverse reactions, including death, in patients with recent severe heart failure. The drug’s label will contain a “black box” warning cautioning that the drug should not be used in patients with severe heart failure.
The approval was based in part on the results of the Athena trial, which evaluated the efficacy and safety of Multaq in patients with AF/AFL or a recent history of these conditions (71% of these patients had no heart failure, 29% were in New York Heart Association [NYHA] Class IIII with stable heart failure). The trial showed that Multaq 400 mg BID, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24% compared with placebo. The most common adverse reactions reported by patients in clinical trials were diarrhea, nausea, vomiting, fatigue and loss of strength.
The manufacturer, Sanofi-Aventis, is required by the FDA to implement a risk evaluation and mitigation strategy (REMS) to ensure the safe use of Multaq and to help healthcare workers identify patients who are appropriate for the treatment.