Modern Medicine
January 14, 2011
Severe liver injury, including 2 cases of acute liver failure leading to liver transplant in patients treated with the medication, has been associated with the use of dronedarone (Multaq), according to an FDA Drug Safety Communication announcement.
Dronedarone is an antiarrhythmic drug indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL) with a recent episode of AF/AFL and associated cardiovascular risk factors (age>70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥50 mm or left ventricular ejection fraction <40%) who are in sinus rhythm or who will be cardioverted.
Since dronedarone’s approval in July 2009 through October 2010, about 492,000 dronedarone prescriptions were dispensed and around 147,000 patients filled dronedarone prescriptions at outpatient retail pharmacies in the United States. Additional usage can occur in the hospital setting.
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