Adverse Drug Reactions Monitoring in Patients on Antitubercular Treatment in Tertiary Care Hospital, Mandya
Kiran M*
and Nagabushan HDepartment of Pharmacology, Mandya Institute of Medical Sciences, Mandya, India.571401.
Corresponding Author E-mail: drkiranmaiya8@gmail.com
Abstract: Background: Tuberculosis is one of the major public health concerns in India. Treatment of tuberculosis need multidrug combinations, which is associated with increased incidence of adverse drug reactions (ADRs). Hence there is a need of active monitoring for adverse effects in patients who are on antitubercular treatment (ATT). Objectives: To study the pattern of ADRs caused by antitubercular drugs and to assess causality, severity and predisposing factors. Methodology: A prospective observational study was conducted for 6 months in tertiary care hospital of Mandya. A total of 74 patients of tuberculosis who experienced ADRs were included in the study after obtaining informed consent. Their demographic, treatment and ADR data were collected and analysed. Causality was assessed using WHO scale and Naranjo’s algorithm, whereas severity was assessed by Modified Hartwig and Siegel scale. Results: Among 74 patients, 55(74.32%) were males and 19 (25.67%) were females. A total of 86 ADRs were recorded amongst 74 patients, as 11 patients experienced two ADRs. During intensive and continuation phase of treatment, 65 (87.63%) and 9 (12.16%)patients experienced ADRs respectively. Gastrointestinal side effects and hepatotoxicity were the most frequently observed ADRs with 23 (26.7%) each, followed by pruritus and rashes in 18 (20.93%) patients.63.51% of ADRs had an association with fixed dose combination (FDC) of isoniazid, rifampicin, pyrazinamide and ethambutol. As per WHO scale and Naranjo’s algorithm majority of ADRs were probable with 44 (59.45%) and 58 (78.37%) respectively. Most of the ADRs belonged to mild (67.56%) category as per Modified Hartwig and Siegel scale. Conclusion: ADRs induced by ATT are common. Hence counselling of patients regarding their life style along with early detection and management will minimize the occurrence of ADRs and improvethe adherence to treatment.
Keywords: Antitubercular Drug Therapy; Naranjo’s Algorithm; Pharmacovigilance; Tuberculosis; WHO Causality Scale Back to TOC