(231) Adverse drug reactions due to antitubercular therapy in multidrug resistant tuberculosis in North east India

Background: Multidrug-resistant tuberculosis (MDR-TB) is usually defined as tuberculosis caused by organisms that are resistant to at least isoniazid and rifampicin. Due to long duration of therapy and concurrent use of multiple second line drugs, Adverse drug reactions (ADR) are regarded as the most important clinical consideration in patients undergoing MDR-TB treatment.Therefore, it is important for physicians to promptly recognize ADR to second line Antitubercular agents and manage them, otherwise there will be failure of treatment

Objectives: To assess the various types of adverse drug reactions related to MDR-TB therapy

Methods: After Institutional ethics approval and obtaining informed written consent, all registered MDR TB patients were included in the study. A pre-structured porforma form was used to collect baseline and patient-specific data. All details of the adverse drug reactions were filled up in the ADR reporting form. MDR-TB patients with suspected adverse drug reactions were assessed using the Naranjo adverse drug reaction probability scale
and Severity assessment of ADRs was also done using the Modified Hartwig and Siegel scale. The data collected from standard proformas were entered and analyzed using Microsoft Excel.

Results: 120 patients with MDR TB were enrolled during the entire course of the study.Majority of the patients were males (62%) as compared to females (38%). 54 ADRs were reported, and the incidence of ADRs was higher in females (57%). It was observed that most of the ADRs were gastrointestinal (nausea and vomitting) (33%), followed by diarrhoea (6%) and psychosis (6%). Majority (61%) of the ADRs were in the “possible” category while on the severity scale, 55% of the ADRs belonged to “mild-level 1”. It was also observed that 48% of the patients with ADR required either change of treatment or discontinuation of the incriminating agent.

Conclusions: The treatment of MDR-TB is prolonged, expensive, more toxic and often unsuccessful. Hence, prevention of MDRTB is more important rather than treatment. Strengthening the program by intensely evaluating treatment regimens, assuring treatment adherence, aggressive and proactive management of adverse events and infection control are very essential to improve outcome in MDR-TB.