Impact of Food and Drug Administration hepatotoxicity warning on prescribing and monitoring of dronedarone in a tertiary teaching hospital

Int J Pharm Pract. 2015 Dec;23(6):456-60. doi: 10.1111/ijpp.12217. Epub 2015 Sep 18.

Abstract

Objectives: 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.

Key findings: 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.

Keywords: adverse drug reactions; patient safety; prescribing.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Amiodarone / administration & dosage
  • Amiodarone / adverse effects
  • Amiodarone / analogs & derivatives*
  • Anti-Arrhythmia Agents / administration & dosage*
  • Anti-Arrhythmia Agents / adverse effects
  • Chemical and Drug Induced Liver Injury / etiology*
  • Chemical and Drug Induced Liver Injury / prevention & control
  • Dronedarone
  • Drug Labeling*
  • Drug Monitoring / methods
  • Female
  • Hospitals, Teaching
  • Humans
  • Liver Function Tests
  • Male
  • Middle Aged
  • Practice Patterns, Physicians' / standards
  • Retrospective Studies
  • Tertiary Care Centers
  • United States
  • United States Food and Drug Administration

Substances

  • Anti-Arrhythmia Agents
  • Dronedarone
  • Amiodarone