Dronedarone Hepatotoxicity — EECC MCQ
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Correct answer: E — Stop dronedarone immediately — hepatotoxicity is a rare but serious adverse effect; dronedarone requires liver function monitoring before and during treatment; it is also contraindicated in HFrEF (ANDROMEDA), permanent AF (PALLAS), and severe hepatic impairment
Dronedarone hepatotoxicity: (1) rare but serious — post-marketing reports of severe hepatic injury (including 2 cases requiring transplant) prompted MHRA/EMA warnings; (2) LFT monitoring is MANDATORY: baseline, then periodically during treatment (at 1 week, 1 month, then every 3 months); (3) if ALT/AST >3x ULN: stop dronedarone and investigate. Additional dronedarone contraindications per the 2024 ESC AF Guidelines: (1) HFrEF or NYHA III-IV (ANDROMEDA trial — increased mortality); (2) permanent AF (PALLAS trial — increased stroke, MI, HF hospitalisation, CV death); (3) severe hepatic impairment; (4) concurrent use with strong CYP3A4 inhibitors. Dronedarone is structurally similar to amiodarone but lacks the iodine moiety — it has fewer extracardiac toxicities (no thyroid, lung, or corneal effects) but also has weaker antiarrhythmic efficacy and these specific safety concerns.
Reference: https://www.nice.org.uk/guidance/conditions-and-diseases/cardiovascular-conditions