Study of adverse drug reactions (ADR’S) requiring change in anti-tubercular regimen in multi-drug resistant tuberculosis (MDR-TB) patients in a tertiary healthcare centre

Abstract

Introduction: Multi Drug Resistant Tuberculosis is fast emerging as a global health problem, especially in developing countries like India with a high Tuberculosis burden and poses a major hurdle in the fight against eliminating Tuberculosis. Considering the long duration of treatment in patients of Multi Drug Resistant Tuberculosis (MDR-TB), it is important to keep an eye on adverse drug reactions (ADR) in these patients during follow up. Severe adverse drug reactions warrant discontinuation of drugs in many patients and can also become a significant factor for poor compliance to second line drugs in Multi Drug Resistant Tuberculosis (MDR-TB) patients.

Materials and Methods: The study was an observational based study conducted in the Department of Pulmonary Medicine of a tertiary healthcare centre in Mumbai between over a period of 1 year. A Total of 60 patients out of 172 patients (34.8%) of MDR-TB having ADR and who required a change in their regimen were identified for the study.

Results: A total of 60 patients of MDR-TB patients were identified who had a change of anti-tubercular regimen due to adverse drug reaction, which were done as per Line Probe Assay (LPA) and Drug Sensitivity Testing (DST) reports of which 38 were females and 22 were males. The most commonly withheld drug was Linezolid in 37 (61.67 %) patients, followed by Cycloserine in 8 patients, Delaminid in 5 patients, Bedaquiline in 4 patients.

Conclusion: Severe ADR’s are one of the commonest requiring change in anti-tubercular regimen, leading to poor adherence and suboptimal treatment, especially when drugs like Bedaquilline, Delaminid, Moxifloxacin and Linezolid are to be discontinued.