Profile of Adverse Drug Reactions in Patients on Treatment for Drug Resistant Tuberculosis: A Cross-sectional Study

Introduction: Tuberculosis (TB) is a communicable disease. India accounted for highest number of TB cases in the world and also share largest burden of Multidrug Drug Resistant (MDR) and Extensively Drug Resistant (XDR) TB cases. Drug Resistant Tuberculosis (DRTB) regimen contains second line anti-TB drugs which are more toxic and likely causes Adverse Drug Reaction (ADR). Severe side-effects and ADRs are one of the main reasons for non-adherence and discontinuation of drug regimen. Aim: To assess the profile of the ADRs in patients on treatment for drug resistant TB. Materials and Methods: The present cross- sectional study was done in DRTB ward of Respiratory Medicine, SCB MCH, Cuttack, Odisha, India. Patients were selected as per inclusion criteria. Adverse reactions were noted by detailed history, general and systemic examination with relevant Laboratory investigations. Causality assessment of ADRs was carried out using Naranjo and World Health Organisation-Uppsala Monitoring Centre (WHO-UMC) algorithm. Severity of ADR was carried out using Modified Hartwig and Seigel scale. Data collected was entered and analysed using IBM Statistical Package for Social Sciences (SPSS) 26, univariate analysis expressing odds ratio and 95% CI was found. Variables with a p-value < 0.05 in univariate analysis are considered significant. Results: Among the 160 DRTB cases enrolled, 85 cases developed ADRs. Among the ADRs Gastrointestinal (GIT) (52.13%) was highest followed by Central Nervous System (CNS) (15.3%) and Cardiovascular System (CVS) (7.69%). Causality assessment done by Naranjo scale showed 72.6% are probable. Among the causality assessment done by WHOUMC, majority were of possible type i.e., 51.3%. The severity assessment using Modified Hartwig and Seigel scale detected majority ADRs are mild type (63.2%). Conclusion: The majority of ADRs are mild and the frequency of ADRs is low in oral bedaquiline containing regimens as compared to previous injectable containing drug resistant regimen. In this study most common ADR is of Gastro intestinal origin and serious ADRs are very rare.