The Food and Drug Administration on Jan. 14 issued a safety announcement about reports of rare but severe liver injury in patients taking dronedarone, including two patients who had acute liver failure that required transplantation.
Dronedarone (Multaq) is used to treat abnormal heart rhythm in patients who have those symptoms for the past 6 months, according to the FDA.
The announcement warned physicians and patients to be alert for signs and symptoms of liver injury or toxicity, including anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching.
Physicians are encouraged to consider ordering periodic hepatic serum enzymes, particularly during the initial 6 months of treatment with dronedarone.
The label’s adverse reactions and warnings and precautions sections are being updated to include information about the potential risk of liver injury.
Adverse events should be reported to MedWatch online or by calling (800) 332-1088.