Pharmacovigilance among patients with multi drug resistance tuberculosis (MDR-TB) treatment-a prospective study

Background: ADRs are frequent in patients of MDR-TB on DOTs-Plus drug regimen. Current study was carried out in tertiary care hospital. Recognition of types and frequency of adverse drug reactions in Intensive and continuation phase of MDR- TB Patients. Methods: It was a prospective observational study conducted in Damien Foundation Urban Leprosy & TB Centre, Nellore. All the MDR-TB patients admitted at the directly observed treatment, short course plus (DOTS plus) Center were enrolled and were monitored for ADRs. The causality and severity of the reactions were determined using Naranjo algorithm. Results: A total of 200 tuberculosis patients of MDR-TB on DOTS therapy were enrolled for the study. Out of 200 patients, 10 were dropouts, 10 defaulted so 190 patients assessed for ADRs, 129 patients developed 109 (56.48%) adverse drug reactions. The higher numbers of ADRs were observed in age group 31- 40yrs followed by 21-30yrs which were more common in men. Majority of adverse drug reactions were Gastrointestinal (GI) problems 48 (37.20%), followed by Ototoxicity 7 (5.42%) and Psychiatric Manifestations 3 (2.321      %) and skin problems 3 (2.32%). On evaluation of the causality of ADRs, majority were found to be Possible (57.95%). The severity assessment showed that most of the patients ADRs were of moderate level (42.04%). Conclusions: ADRs are major factor limiting completion of drug therapy under RNTCP and occurrence of drug resistance which requires attention of all health care professionals.