title: Proarrhythmic potential of dronedarone: emerging evidence from spontaneous adverse event reporting.
abstract: OBJECTIVE
  To characterize the frequency and type of cardiac events, including torsade de pointes, associated with dronedarone and its structural analog, amiodarone, outside of the clinical trial setting.
  
  
  METHODS
  Retrospective analysis.
  
  
  METHODS
  Spontaneous reports in the United States Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database generated between July 1, 2009, and June 30, 2011.
  
  
  RESULTS
  All reports of adverse events during the study period were reviewed to identify cardiac events associated with any approved drug in the United States. The type and number of cardiac events associated with dronedarone and amiodarone were determined. Active ingredients were identified using the Drugs@FDA database, and the Medical Dictionary for Regulatory Activities (MedDRA) was used to aggregate related adverse events. To avoid redundant reporting, all statistics were generated in reference to unique case identifiers. Dronedarone was associated with more adverse cardiovascular event reports than amiodarone (810 vs 493 reports) during the study period. Dronedarone was also associated with the most reports of torsade de pointes of any approved drug in the United States (37 reports), followed by amiodarone (29 reports). Reports of ventricular arrhythmias and cardiac arrest (138 vs 113 reports) as well as heart failure (179 vs 126 reports) were more common with dronedarone than amiodarone.
  
  
  CONCLUSIONS
  Dronedarone was associated with reports of ventricular arrhythmia, cardiac arrest, and torsade de pointes in clinical practice. Whether this observation accounts for the increased risk of fatal arrhythmia observed in a recent prospective trial requires further investigation.
authors: Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA.
authors: David P
authors: DP
authors: Kao
authors: William R
authors: WR
authors: Hiatt
authors: Mori J
authors: MJ
authors: Krantz
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D000638:Amiodarone / Q000009:adverse effects / Q000031:analogs & derivatives*; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects*; D001145:Arrhythmias, Cardiac / Q000139:chemically induced* / Q000453:epidemiology / Q000503:physiopathology; D000077764:Dronedarone; D006323:Heart Arrest / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D012189:Retrospective Studies; D016171:Torsades de Pointes / Q000139:chemically induced / Q000453:epidemiology; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000889:Anti-Arrhythmia Agents; D000077764:Dronedarone; D000638:Amiodarone