title: Impact of Food and Drug Administration hepatotoxicity warning on prescribing and monitoring of dronedarone in a tertiary teaching hospital.
abstract: OBJECTIVE
  The purpose of this study was to determine the impact of a Food and Drug Administration (FDA) hepatotoxicity warning on 14 January 2011 on the prescribing practices and hepatic monitoring of patients receiving dronedarone.
  
  
  METHODS
  Patients who received dronedarone 1 year before and after the FDA warning were retrospectively evaluated for the appropriateness of dronedarone prescribing, hepatic injury evaluation and medication discontinuation rates in a tertiary medical centre.
  
  
  RESULTS
  Ninety-one patients (66.4%) were prescribed dronedarone prior to the FDA warning, compared with 46 patients (33.6%) after the warning. The frequency of liver function testing (72.5% versus 76.1%) and discontinuation rates (42.9% versus 50%) were similar before and after the FDA warning.
  
  
  CONCLUSIONS
  There was no significant change in dronedarone prescribing practice, monitoring of hepatic function or discontinuation rates following an FDA hepatotoxicity warning.
authors.affiliation: Department of Pharmacy Practice, Chicago College of Pharmacy, Midwestern University, Downers Grove, IL, USA.
authors.forename: Sally A
authors.initials: SA
authors.lastname: Arif
authors.affiliation: Department of Pharmacy Practice, Froedtert and the Medical College of Wisconsin, Kansas City, MO, USA.
authors.forename: Rachel
authors.initials: R
authors.lastname: Drury
authors.affiliation: Department of Pharmacy, University of Chicago Medical Center, Chicago, IL, USA.
authors.forename: Pamela
authors.initials: P
authors.lastname: Ader
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000638:Amiodarone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage* / Q000009:adverse effects; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology* / Q000517:prevention & control; D000077764:Dronedarone; D004348:Drug Labeling; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D006784:Hospitals, Teaching; D006801:Humans; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D010818:Practice Patterns, Physicians' / Q000592:standards; D012189:Retrospective Studies; D062606:Tertiary Care Centers; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000889:Anti-Arrhythmia Agents; D000077764:Dronedarone; D000638:Amiodarone
keywords: adverse drug reactions; patient safety; prescribing