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

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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.


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.


There was no significant change in dronedarone prescribing practice, monitoring of hepatic function or discontinuation rates following an FDA hepatotoxicity warning.

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