FDA Alert Regarding Liver Injury Associated with Dronedarone

January 20, 2011 1:10 pm Topics: Patient safety

FDA alerts health care providers about cases of rare, but severe liver injury, associated with dronedarone (Multaq^®), a drug used to treat abnormal heart rhythm in patients who have had an abnormal heart rhythm (atrial fibrillation or atrial flutter) in the past six months. Two patient cases resulted in acute liver failure leading to liver transplant.

FDA reports that dronedarone was approved with a Risk Evaluation and Mitigation Strategy with a goal of preventing its use in patients with severe heart failure or who have recently been in the hospital for heart failure. Information about the potential risk of liver injury from dronedarone will now be added to the warnings and precautions and adverse reactions sections of the dronedarone labels. Detailed information for patients and health care providers is available in an FDA Drug Safety Communication.