Profile of adverse drug reactions in multiple drug resistant tuberculosis patients at drug resistant-tuberculosis center - Miraj, Maharashtra

Abstract

Background: Drug resistant tuberculosis (DR-TB) has been an emerging global public health threat and area of serious concern on to global efforts of TB control initiative. Objectives: To elucidate the profile of adverse drug reactions (ADRs) associated with antitubercular treatment regime for DR-TB. Materials and Methods: A retrospective, record-based, observational type of epidemiological study was conducted on multi DR (MDR)-TB patients. The sample size includes, total of 468 patients were admitted in DR-TB center Miraj during year 1st July 2013 to 30th June 2015. A structured pro forma was designed and utilized to collect the data that include variables on ADR profile of diagnosed MDR-TB cases on supervised DOTS-Plus regimen under programmatic management of DR-TB under Revised National Tuberculosis Control Program. The data were analyzed into frequency percentage distribution and presented in tabular form. Results: Out of total 468 MDR-TB patients, 12.82% were reported with ADRs. Out of total 109 ADRs, gastrointestinal upset was maximum, 5.98% followed by psychosis 4.91%, hearing impairment 2.99%, and rest were in between 0.21% and 1.49%, respectively. Max, 56.67% ADRs were seen in undernourished patients with major involvement pertained to central nervous system. Around, 50% ADRs were managed by symptomatically, whereas others were managed by changing the antitubercular drug (33.33%), use of vitamin B6 and use of antidepressant. Conclusion: Early detection, management and reporting of ADRs remain key factors in the management of MDR-TB with remarkable relevance to prevent emergence threat of global MDR-TB.