Topic Reviews A-Z
Dronedarone Topic Review
Dronedarone is a class III antiarrhythmic drug used for the treatment of paroxysmal and persistent atrial fibrillation and atrial flutter.
There are structural similarities of dronedarone to amiodarone; however, no iodine is present in the chemical structure of dronedarone (Multaq, Sanofi), which has resulted in dramatically reduced toxicity compared to amiodarone (see Amiodarone Toxicity Topic Review). However, dronedarone has a lower efficacy than amiodarone.
Indications
Dronedarone is used solely to maintain sinus rhythm in patients with paroxysmal and persistent atrial fibrillation (AF) and atrial flutter. [Multaq package insert;1a]
Adverse effects
Hepatic dysfunction is the main concern. Rare cases of fulminant hepatic failure have been reported, leading to an FDA advisory in January 2011. In that advisory, the FDA suggested that health care professionals consider obtaining periodic hepatic serum enzymes for patients prescribed dronedarone, especially during the first 6 months of treatment, and discontinue the drug and test serum liver enzymes and bilirubin if hepatic injury is suspected. [FDA Drug Safety Communication, Jan. 14, 2011]
Other adverse effects include bradycardia, heart failure (HF), hypotension and QT prolongation. [Multaq package insert;1a-b]
Guideline recommendations
The 2023 American College of Cardiology/American Heart Association/American College of Clinical Pharmacy/Heart Rhythm Society Guideline for the Diagnosis and Management of Atrial Fibrillation includes the following recommendations regarding dronedarone:
Use of dronedarone is reasonable (Class 2a recommendation) for long-term maintenance of sinus rhythm in patients with AF without recent decompensated HF or severe left ventricular dysfunction. [Joglar JA, et al. J Am Coll Cardiol. 2023;85a]
Due to elevated risk for early mortality associated with worsening HF, dronedarone should not be used (Class 3 recommendation: Harm) in patients with class III or IV HF who have had an episode of decompensated HF in the past 4 weeks. [Joglar JA, et al. J Am Coll Cardiol. 2023;85a,102a]
Miscellaneous
Dronedarone is contraindicated if left ventricular systolic dysfunction is present since clinical trials showed an increase in deaths from HF.
Dronedarone is not indicated or recommended if AF or atrial flutter is permanent. [Joglar JA, et al. J Am Coll Cardiol. 2023;70a]
Dronedarone is not used for ventricular arrhythmias.
References:
- FDA Drug Safety Communication: Severe liver injury associated with the use of dronedarone (marketed as Multaq). https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-severe-liver-injury-associated-use-dronedarone-marketed-multaq. Published Jan. 14, 2011. Accessed Sept. 6, 2024.
- Joglar JA, et al. J Am Coll Cardiol. 2023;doi:10.1016/j.jacc.2023.08.017.
- Multaq package insert; Sanofi. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf. Accessed Dec. 19, 2023.