Severe liver injury associated with the use of dronedarone (Multaq®)

Sanofi-aventis updates healthcare professionals on overseas post-marketing cases of severe liver injury,including two case reports of acute liver failure requiring transplantation in patients treated with Multaq®. The two case reports of liver transplantation occurred at 4.5 and 6 months after initiation of treatment in patients with normal baseline liver function tests. Although both patients were taking concomitant medication, a causal relationship with dronedarone (Multaq®) could not be excluded. Healthcare professionals are advised to perform liver function test monitoring in patients being prescribed dronedarone and to advise their patients to report symptoms of potential liver injury such as sustained new onset abdominal pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine or itching. Healthcare professionals are encouraged to refer to the updated Multaq® package insert available on HSA website for more details.