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

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.