1. Hepatic adverse drug reactions in Malaysia: An <scp>18‐year</scp> review of the national centralized reporting system
- Author
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Norleen Mohamed Ali, Haniza Omar, Huan-Keat Chan, Noor Aliza Mutalib, Hin-Seng Wong, Fei Yee Lee, and Muhammad Radzi Abu Hassan
- Subjects
medicine.medical_specialty ,Databases, Factual ,Drug-Related Side Effects and Adverse Reactions ,Epidemiology ,Population ,Amiodarone ,030226 pharmacology & pharmacy ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Pharmacovigilance ,medicine ,Adverse Drug Reaction Reporting Systems ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,education ,Retrospective Studies ,education.field_of_study ,business.industry ,Incidence (epidemiology) ,Mortality rate ,Malaysia ,Odds ratio ,Pharmacoepidemiology ,medicine.disease ,business ,Adverse drug reaction ,medicine.drug - Abstract
PURPOSE To determine the incidence, demographic profile, background of reporters, causative agents, severity and clinical outcomes of hepatic adverse drug reaction (ADR) reports in Malaysia using the national ADR reporting database. METHODS The ADR reports recorded between 2000 and 2017 were retrospectively analysed to identify hepatic ADR reports. The trend and characteristics of hepatic ADR cases were described. Multivariate disproportionality analysis of the causative agents was performed to generate signals of hepatic ADRs. RESULTS A total of 2090 hepatic ADRs (1.77% of all ADRs) were reported with mortality rate of 12.7% among cases with known clinical outcomes. The incidence of hepatic ADR reporting in Malaysia increased significantly over 18 years from 0.26 to 9.45 per million population (P
- Published
- 2020