Ambispective study of adverse drug reactions in multi-drug resistant tuberculosis patients in Warangal, Telangana

Abstract

Background: Multidrug-resistant tuberculosis (MDR-TB) has become a global threat concerning to a risk of high mortality with the potential to cause adverse drug reactions (ADRs) which if not managed properly may affect patient compliance, resulting in below par treatment outcome. Aim: The aim of the study was to study, assess, and report the ADRs of patients diagnosed with MDR-TB. Subjects and Methods: An ambispective, observational study was conducted among confirmed cases of MDR-TB patients without any comorbidities during the period of January 2015–December 2018 in patients of age 15 years and above. Statistical Analysis: Data were analyzed descriptively using MS-Excel sheet 2013 and Chi-square test in GraphPad Prism 8.2.1. Results were expressed as either frequency, percentage, or mean ± standard deviation. ADRs were evaluated for causality, severity, and preventability attributes. Results: In the sample size of 400 patients, 236 (ADRs) were reported among 136 patients. The proportion of ADRs was higher in males (P = 0.0001) and in the age group of 36–75 years (P = 0.0211). Most commonly encountered ADRs include nausea and vomiting (35.31%) and arthralgia (14.04%), followed by peripheral neuropathy (8.93%) and giddiness (8.93%). Overall, 53% were of possible category and 60% of moderate level severity and 85% were unpreventable ADRs. Conclusion: Our study included 13 types of ADRs, of which most commonly reported were nausea and vomiting, arthralgia, and peripheral neuropathy and least common were psychosis, nephrotoxicity, and gynecomastia with a higher incidence in males. Majority of ADRs were moderate, unpreventable ADRs and had a possible relationship with the suspected drugs.

Keywords

• adverse drug reaction
• causality
• multidrug resistant tuberculosis
• preventability assessment
• severity