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.

A Retrospective Study of Adverse Drug Reaction in Multidrug-Resistant Tuberculosis Patients at Tertiary Care Hospital

“…In the present study, the majority of ADRs were found mild (41.30%) and moderate (40.22%) followed by severe (18.48%). These results were dissimilar to those obtained in the study conducted by Fatima et al [16].…”

“…In our study, male (67.65%) patients were more affected due to adverse drug reactions as compared to females (32.35%) which were similar to the study conducted by Rathod et al [14] and Fatima et al [16].…”

“…Another study result totally reversed that 84.74% of ADRs were not preventable. This study was done by Fatima et al [16].…”

“…As per the global TB report 2021, the total number of incident TB patients notified during 2021 was 1,933,381, which was 19% higher than that of 2020 (16,28,161) [2]. Globally, about a half-million new cases of rifampicin-resistant TB (RR-TB) occurred in 2019, with 78% of them having confirmed MDR-TB as per the guidelines for programmatic management of drug-resistant TB in India by 2021.…”