Dronedarone (Multaq): Potential for Severe Liver Injury
January 19, 2011
FDA is informing healthcare professionals and patients that severe liver injury, including hepatocellular injury and acute hepatic failure requiring liver transplant, has been reported in patients taking dronedarone (Multaq). The “Warnings and Precautions” and “Adverse Reactions” sections of the product labeling have been updated to include information regarding this potential risk. According to post-marketing case reports, acute hepatic failure with extensive hepatocellular necrosis occurred in two female patients (mean age of 70 years) after taking dronedarone. These patients had normal serum hepatic enzymes prior to treatment with dronedarone. Both patients ultimately required liver transplants. One patient had a past medical history of atrial fibrillation, arterial hypertension, and stable coronary artery disease. After 4.5 months of treatment with dronedarone, she was admitted to the hospital with coagulopathy, hyperbilirubinemia, jaundice, transaminitis, and subsequently developed hepatic encephalopathy within nine days. The other patient had a past medical history of paroxysmal atrial fibrillation and Sjogren’s syndrome. After 6 months of treatment with dronedarone she experienced abdominal pain, coagulopathy, hyperbilirubinemia, transaminitis, and weakness. The patient received a liver transplant one month after the presence of these symptoms.
Patients should seek help from a healthcare professional if they are experiencing signs and symptoms of liver dysfunction while taking dronedarone. These may include symptoms such as anorexia, dark urine, fatigue, fever, itching, jaundice, right upper quadrant pain, nausea, and vomiting. Consider performing appropriate laboratory testing of serum hepatic enzymes and bilirubin during initiation of therapy, within the first 6 months. It is unknown whether routine testing will stop the development of severe liver injury. Discontinue dronedarone if liver injury is suspected and perform serum liver enzyme and bilirubin laboratory tests. Do not restart dronedarone in patients with a history of liver injury associated with dronedarone. Patients are advised to read the medication guide that accompanies dronedarone. Report any adverse events to the MedWatch program.
Additional information is available at the following link:
- Drug Safety Communication:
January 19, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.