Frequency and type of adverse drug reactions related to multidrug-resistant tuberculosis therapy

Abstract

Background: Adverse drug reactions (ADRs) are inevitable consequences of multidrug-resistant tuberculosis drug therapy. Reporting of ADR in India is poor and inadequate. ADRs monitoring forms an integral part of pharmacovigilance. ADRs with second line anti-tuberculous therapy (ATT) have been mentioned as obstacles in the management of multidrug-resistant tuberculosis (MDR-TB). Objectives of the study was to study the frequency and type of adverse drug reaction related to MDR-TB therapy.Methods: 72 patients diagnosed as MDR-TB and enrolled for DOTS-PLUS (CAT.IV) regimen at NTEP centre, KIMS HUBLI were included. This was a prospective observational study. All patients were followed up for a period of 9 months from the day of commencement of treatment. Adverse drug reactions were determined by monthly clinical and biochemical monitoring of patients to identify ADRs.Results: Among 72 Patients, 42 (58.3%) were males. 44 out of 72 patients experienced at least one type of ADRs (61.1%). Mean age was 35.86±12.62 and mean weight was 42.00±9.05. Four most common ADRs reported were Gastro-intestinal symptoms (29.2%), anorexia (15.3%), giddiness (12.5%), and pain at injection site (11.1%). Highest percentage of ADRs were seen in patients of age group>60 years (66.7%). ADRs were most commonly reported in first 3 months of initiation of therapy. 9 out of 72 patients (12.5%) or 20.5% of 44 patients who showed ADRs required change of treatment. There was a significant impact of ADRs on treatment among those with ADRs (p=0.01).Conclusion: ADRs of varying severity are common in patients of MDR-TB on DOTS-PLUS regimen, occurring in more than half of the cases, with around one fifth requiring change of MDR-TB treatment.