Adverse Drug Reactions to First Line Anti-Tubercular Drugs - A Pharmacovigilance Study

Introduction: Tuberculosis is one of the major health problems in India and developing countries. It is the second leading infectious cause of morbidity and mortality in the world. Objective: The present study was undertaken to study the Adverse Drug Reactions (ADRs) to first line Anti-tubercular drugs (ATTs) prescribed to tuberculosis patients admitted to Medicine Department, BTGH, attached to M.R. Medical College, Gulbarga. Materials and Methods: A Prospective Observational study was carried among tuberculosis patients on Directly Observed Short Course Chemotherapy (DOTS), admitted to Medicine Department, BTGH, attached to M.R. Medical College; Gulbarga.120 Patients were included during the study period of 9 months from 1 st October 2014 to 30 th June 2015. The data was collected in a Proforma which included questionnaire. Results: A total of 120 tuberculosis patients on DOTS were enrolled for the study. Out of 107 patients, 63 patients (58.87%) developed ADRs. Out of 63 patients, 32 patients (51%) developed Gastro-intestinal problems, 14 patients developed CNS problems (22%), 11 patients (18%) developed Hepatitis, 4 patients (6%) developed Fever and 2 patients (3%) developed Pancreatitis. The most serious ADR was Hepatitis. Conclusion: Results of the study reveals that about 58.87% of patients developed ADRs during the study period. These ADRs will lead to stoppage of drugs, development of Drug resistance and Therapeutic Failure. If a proper Pharmacovigilance system is implemented in the hospital, most of the patients may report their ADRs and thereby we can improve the patient adherence and treatment outcome.