Severe toxic hepatitis associated with dronedarone

Curr Drug Saf. 2013 Jul;8(3):201-2. doi: 10.2174/15748863113089990031.

Abstract

Dronedarone was introduced in 2009 as a new antiarrhythmic agent and since then has been increasingly prescribed in atrial fibrillation or flutter. To date, two cases of severe toxic hepatitis have been reported in patients treated with dronedarone, both requiring emergency liver transplantation, and the FDA as well as the EMA have issued warnings about possible severe hepatotoxicity of dronedarone. Here we report an additional case of toxic hepatitis associated with dronedarone presenting with acute liver failure, followed by spontaneous recovery, in a 69-year old woman.

Publication types

  • Case Reports

MeSH terms

  • Aged
  • Amiodarone / adverse effects
  • Amiodarone / analogs & derivatives*
  • Amiodarone / therapeutic use
  • Anti-Arrhythmia Agents / adverse effects*
  • Anti-Arrhythmia Agents / therapeutic use
  • Atrial Fibrillation / drug therapy
  • Chemical and Drug Induced Liver Injury, Chronic / etiology*
  • Chemical and Drug Induced Liver Injury, Chronic / physiopathology
  • Dronedarone
  • Female
  • Humans
  • Severity of Illness Index

Substances

  • Anti-Arrhythmia Agents
  • Dronedarone
  • Amiodarone