Hepatic adverse drug reactions in Malaysia: An 18‐year review of the national centralized reporting system
| Autor: | Norleen Mohamed Ali, Haniza Omar, Huan-Keat Chan, Noor Aliza Mutalib, Hin-Seng Wong, Fei Yee Lee, Muhammad Radzi Abu Hassan |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
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 |
| Zdroj: | Pharmacoepidemiology and Drug Safety. 29:1669-1679 |
| ISSN: | 1099-1557 1053-8569 |
| DOI: | 10.1002/pds.5153 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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