FDA Approves Multaq for Heart Arrhythmias

Multaq for Heart Arrhythmias

Earlier this week the FDA approved Multaq tablets (dronedarone) in the treatment of heart arrhythmias. The irregular heart rhythms include atrial fibrillation and atrial flutter.

In a multinational clinical trial with more than 4,600 patients, Multaq reduced cardiovascular hospitalization or death from any cause by 24 percent, when compared with an inactive pill (placebo). Atrial fibrillation and atrial flutter cause the heart to beat abnormally fast. This excessive rate often prevents blood from being properly pumped out of the heart.

Atrial fibrillation/flutter can affect both men and women. It becomes more common with increasing age. Causes can include alcohol use, congestive heart failure, coronary heart disease, heart surgery, hypertension, and hyperthyroidism.


Symptoms may include rapid pulse rate, shortness of breath, confusion, dizziness, light-headedness, fainting, and fatigue. The heart rate in atrial fibrillation/flutter runs 100-175 and may be regular or irregular. The normal heart rate is 60 – 100.

Multaq is the first new anti-arrhythmic therapy to be approved in over 10 years. It will be sold in 400-milligram tablets intended to be taken twice a day. Multaq is manufactured by Paris-based sanofi-aventis.

The most common adverse reactions reported by patients in clinical trials were diarrhea, nausea, vomiting, fatigue and loss of strength. Because Multaq may cause critical adverse reactions, including death, in patients with recent severe heart failure, the drug’s label will contain a boxed warning. The warning will caution that the drug should not be used in severe heart failure patients.

FDA News Release
National Institute of Health