| Summary: | Background An urgent need for coronavirus infectious disease (COVID-19) treatment has resulted in off-label drug use. Although previous studies had investigated the adverse drug reaction (ADR) of the medications for COVID-19 in their respective local settings, the safety profile in a Malaysian setting remains unknown. Our study aims to establish the incidence of ADR for drugs used in COVID-19 management in a Malaysian tertiary hospital. Methods This retrospective observational study enrolled patients started on drugs for COVID-19 in Sungai Buloh Hospital from 1 March 2020 to 31 May 2020. The clinical staging of COVID-19 patients was decided by the treating physician in accordance with the Clinical Management of Confirmed COVID-19 Case in Adults (Annex 2E). Suspected ADRs were evaluated with a trigger tool of pre-defined laboratory values or the adverse events listed in the registered product insert. Causality assessment was conducted when an ADR was suspected using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system, and only cases classified as certain, probable and possible ADR were considered. Data analysis was completed with descriptive, univariate and multivariate analysis. Results The study (N = 1,080) identified 217 patients (20.1%) who experienced ADR, with 246 adverse events detected. Most events were related to the gastrointestinal (43.5%), hepatobiliary (36.2%) and cardiac (16.3%) systems. The most commonly suspected drugs were atazanavir (52.7%), chloroquine (36.8%) and lopinavir/ritonavir (34.6%). The independent risk factors of ADR were female (adjusted odds ratio (OR): 1.53; 95% CI 1.06–2.20; P = 0.024), diagnosis of COVID-19 stage 3 (adjusted OR: 2.58; 95% CI 1.20–5.55; P = 0.015) and stage 4 (adjusted OR: 4.17; 95% CI 1.79–9.73; P = 0.001), and the number of COVID-19 drugs (adjusted OR: 3.34; 95% CI 2.51–4.44; P < 0.001). Only 49 adverse events (19.9%) were manually reported by healthcare professionals, with hyperbilirubinaemia (65.3%) and QT prolongation (28.6%) most frequently reported. Conclusion Medications used in COVID-19 management had resulted in one in five patients experiencing ADR. Our study has provided an overview on incidence of ADR for off-label use of medications used in COVID-19 management, which suggests a similar safety profile when used for FDA-approved indications.
|
|---|