Causality, severity, and preventability of adverse drug reactions due to multi-drug therapy in leprosy: evidence from a national level institution in Sri Lanka

Objective This study describes the causality, severity, and preventability of adverse drug reactions (ADR) in patients affected by leprosy treated with multi-drug therapy (MDT) at dermatology central clinics National Hospital Sri Lanka. Methods cross-sectional analytical consisted two components (retrospective prospective). Prospective cases were recruited followed up for six months. Retrospective data collection was carried out relevant NHSL extracting from clinical records patients. When an ADR suspected, it confirmed after discussion clinic medical officers/consultant dermatologist scored according to Naranjo probability scale. The intensity individual evaluated using modified Hartwig Siegel Severity Assessment Scale, assessment performed Schumock Thornton Results One hundred ninety-seven included attributable MDT. Approximately 145 (73.6%) developed associated dapsone. Another 50 (25.3%) rifampicin, 10 (5.1%) clofazimine. Of dapsone related ADRs, 59 (40.7%) definite, 64 (44.1%) probable, 22 (15.2%) possible. rifampicin-related cases, four (8%) 35 (70%) 11 (22%) most common detected haemolytic anaemia hepatic abnormalities due Dapsone discontinued 40% (59 145) these patients, while rifampicin stopped 8% (4 50) Clofazimine not any Conclusions Adverse multidrug are among diagnosed Most ADRs reported this mild severity preventable. Careful monitoring objective scales needed identify early stage.