Sally A Arif1, Rachel Drury2, Pamela Ader3. 1. Department of Pharmacy Practice, Chicago College of Pharmacy, Midwestern University, Downers Grove, IL, USA. 2. Department of Pharmacy Practice, Froedtert and the Medical College of Wisconsin, Kansas City, MO, USA. 3. Department of Pharmacy, University of Chicago Medical Center, Chicago, IL, USA.
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.
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.
Authors: Esther de Vries; Elisabeth Bakker; Remy D C Francisca; Stijn Croonen; Petra Denig; Peter G M Mol Journal: Drug Saf Date: 2022-03-29 Impact factor: 5.228