Trends in reporting drug-associated liver injuries in Taiwan: a focus on amiodarone
Journal
International journal of clinical pharmacy
Journal Volume
40
Journal Issue
4
Pages
911
Date Issued
2018-08
Author(s)
Abstract
Background A pharmacovigilance database of real-world adverse drug reaction (ADR) reports is helpful for characterising adverse events and identifying new signals after drug approval. Objective This study aimed to analyse trends of ADR reporting in relation to liver injury and to delineate critical factors for suspected drug-related hepatotoxicity with a focus on reports associated with amiodarone. Setting The 2000-2014 Taiwan pharmacovigilance database. Method Relevant Standardized Medical Dictionary for Regulatory Activities queries were used to identify reports associated with liver injury. Information on ADR, patient characteristics, and the verbatim pertaining to amiodarone prescriptions, liver injury, comedications, and comorbidities were extracted and evaluated. Group comparisons between Hy's Law cases and Temple's Corollary cases of suspected amiodarone-related hepatotoxicity were performed. Main outcome measure Number and nature of drug-related liver injuries, particularly those associated with amiodarone. Results Of the 98,777 ADR reports over a 15-year period, 4261 (4.3%) were related to liver injury. Sixty-eight reports contained amiodarone prescriptions, but only 49 (1.1%) were eligible for further analysis. Hepatotoxic cases associated with amiodarone mostly occurred within 1 week, exhibited a hepatocellular pattern, and were more common among elderly individuals. Among 23 discernible cases, four (17.4%) recovered fully from liver injury. The critical Hy's Law cases were associated with shorter height, lower body surface area, and higher average daily doses. Conclusion This study substantiates the importance of ADR reporting. Data pertaining to drug-associated liver injury and factors associated with suspected amiodarone-related hepatotoxicity warrants continual attention in pharmacovigilance for those at risk, especially the elderly.
Subjects
Adverse drug reactions; Amiodarone; Hepatotoxicity; MedDRA-coded database; Pharmacovigilance; Taiwan
SDGs
Other Subjects
amiodarone; amiodarone; antiarrhythmic agent; adult; aged; Article; clinical article; demography; disease registry; drug induced disease; female; human; liver injury; liver toxicity; male; outcome assessment; physicochemical model; prescription; priority journal; retrospective study; risk factor; Taiwan; trend study; very elderly; age; body height; body surface; dose response; drug surveillance program; factual database; middle aged; patient safety; risk assessment; time factor; toxic hepatitis; trends; Adult; Adverse Drug Reaction Reporting Systems; Age Factors; Aged; Aged, 80 and over; Amiodarone; Anti-Arrhythmia Agents; Body Height; Body Surface Area; Chemical and Drug Induced Liver Injury; Databases, Factual; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged; Patient Safety; Pharmacovigilance; Retrospective Studies; Risk Assessment; Risk Factors; Taiwan; Time Factors
Type
journal article