ASSESSMENT OF ADVERSE DRUG REACTIONS IN TUBERCULOSIS PATIENTS OF SOUTH INDIA

Abstract

Back ground: Tuberculosis (TB) has become one of the biggest public health challenges in India currently. India is one of the six countries accounted for 60% of the new cases in 2015. Objective(s): To monitor ADRs and report the occurrence of ADRs, their extent and severity with first line drugs. Material(s) and Method(s): The study was a prospective observational, hospital based case control study conducted in Govt. Infectious disease hospital, Guntur, India. The incidence of adverse drug reactions were identified and causality, severity were also analyzed. Result(s): The record of 308 ADRs was reported among 182(45.5%) patients with ADR occurrence of 1.69 per patient. Of the participants, 264(66%) were male. Maximum number of ADRs were seen in retreatment cases which was proved statistically (P=0.0027). There was a strong significant difference between HIV infected (OR= 3.69, 95% CI= 1.31-2.91; P < 0.0001) and HIV uninfected in occurrence of ADRs. Significant difference was found in total number of ADRs in Cat-I and Cat-II patients. Among 308 reported ADRs, tingling and numbness 34(11.04%) and anorexia 34(11.04%) were the most common ADRs reported. Maximum ADR events were mild 143(46.4%) followed by moderate 131(42.5%) and severe 34(11.0%). The most offending drug for causing ADRs is Isoniazid (32.47%), followed by Pyrazinamide (27.59), Rifampicin (24.36), Ethambutol (11.36) and Streptomycin (11.36%). Conclusion(s): This research creates the importance of close monitoring of patients who were at higher risk of getting ADRs by health care team and necessary steps should be taken in selecting the right drug regimen.Copyright © 2019 International Research Journal of Pharmacy. All rights reserved.