Adverse drug reactions and treatment outcome analysis of DOTS-plus therapy of MDR-TB patients at district tuberculosis centre: A four year retrospective study

Background: Treatment of multidrug-resistant tuberculosis (MDR-TB) requires the use of expensive and toxic second-line anti-tubercular drugs which are given for a longer duration. Adverse drug reactions (ADRs) of second-line antitubercular drugs affect compliance and thereby treatment outcome. We set out to analyze ADRs and treatment outcome of MDR-TB patients receiving directly observed treatments plus therapy. Materials and Methods: A retrospective study of registered MDR-TB cases at district tuberculosis center during 2010–2014 was performed. Data regarding sociodemographic profile, diagnosis, and treatment as well as ADRs were recorded and evaluated. ADRs were evaluated for causality, severity assessment, management aspects, and impact on treatment outcome. Results: In total 147 ADRs were reported among 72 cases. Most commonly observed ADRs were gastrointestinal (24.5%) followed by self reported weakness (21.23%), psychological (14.38%), joint pain (14.38%), and respiratory symptoms. Discontinuation of the drugs due to ADRs was required in 36 (24.48%) events. ADRs were significantly associated with nontreatment adherence and defaulter outcome. Cure rate was higher in MDR-TB cases with ADRs (59.72%) than MDR-TB cases without ADRs (30.18%). Conclusion: Attention needs to be paid for timely recognition and treatment of ADR with minimum modification of treatment regimen. Equal attention should be paid to MDR-TB without ADR cases to raise over all cure rate