Evaluation of adverse drug reactions in patients receiving second-line therapy for multidrug-resistant tuberculosis
DOI:
https://doi.org/10.18203/2320-6012.ijrms20260631Keywords:
Multidrug-resistant tuberculosis, Adverse drug reactions, Second-line anti-tubercular drugs, Pharmacovigilance, Retrospective studyAbstract
Background: Multidrug-resistant tuberculosis (MDR-TB) poses a major challenge to tuberculosis control, particularly in high-burden countries like India. Treatment of MDR-TB requires prolonged use of second-line anti-tubercular drugs, which are frequently associated with adverse drug reactions. These adverse drug reactions (ADRs) can adversely affect treatment adherence, increase morbidity, and compromise overall treatment outcomes, highlighting the importance of systematic pharmacovigilance. Aim of the study was to analyze the pattern, frequency, and spectrum of adverse drug reactions associated with anti-tubercular drugs in patients with MDR-TB.
Methods: A retrospective descriptive study was conducted among 178 adult MDR-TB patients treated at a tertiary care center between January and December 2024. Patient records were reviewed for demographic details, clinical characteristics, treatment regimens, and reported ADRs. ADRs were categorized by organ system involvement, assessed for causality using the Naranjo scale, and graded for severity using the Hartwig and Siegel scale. Data were analyzed using descriptive statistics.
Results: MDR-TB was more common among males and individuals aged ≤40 years. Endocrine ADRs (18.3%) were the most frequently reported, followed by otic toxicity (14.6%), musculoskeletal complaints (13.5%), and gastrointestinal disturbances (11.4%). Hepatic, dermatological, neurological, and renal ADRs were also observed.
Conclusions: ADRs are common among MDR-TB patients receiving second-line therapy. Early detection, regular monitoring, and strengthened pharmacovigilance are essential to improve treatment adherence and outcomes.
Metrics
References
World Health Organization. Global tuberculosis report 2024. Geneva: WHO. 2024. Available at: https://www.who.int/teams/global-programme-on-tuberculosis-and-lung-health/tb-reports/global-tuberculosis-report-2024. Accessed on 10 November 2025.
World Health Organization. WHO consolidated guidelines on tuberculosis: Module 4: treatment - drug-resistant tuberculosis treatment, 2022 update. Available at: https://www.ncbi.nlm.nih.gov/books/ NBK588564/. Accessed on 10 November 2025.
Central TB Division. India TB Report 2023. Ministry of Health and Family Welfare, Government of India. 2023. Available at: https://tbcindia.mohfw.gov.in/wp-content/uploads/2023/05/5646719104TB_AR_2023_04-04-2023_LRP_final.pdf. Accessed on 10 November 2025.
Kurz SG, Furin JJ, Bark CM. Drug-resistant tuberculosis: challenges and progress. Infect Dis Clin North Am. 2016;30(2):509-22. DOI: https://doi.org/10.1016/j.idc.2016.02.010
World Health Organization. WHO consolidated guidelines on tuberculosis: Module 4: Treatment - Drug-susceptible tuberculosis treatment. 2022. Available at: https://pubmed.ncbi.nlm.nih.gov/ 35727905/. Accessed on 10 November 2025.
Migliori GB, Lange C, Centis R. Resistance to second-line injectables and treatment outcomes. Eur Respir J. 2018;52:1801524.
Duggal P, Sarkar M. Audiologic monitoring of multidrug-resistant tuberculosis patients on aminoglycoside treatment. Int J Tuberc Lung Dis. 2007;11(1):115-8. DOI: https://doi.org/10.1186/1472-6815-7-5
Törün T, Güngör G, Ozmen I, Bölükbaşi Y, Maden E, Biçakçi B, et al. Side effects associated with the treatment of multidrug-resistant tuberculosis. Int J Tuberc Lung Dis. 2005;9(12):1373-7.
Nathanson E, Gupta R, Huamani P, Leimane V, Pasechnikov AD, Tupasi TE, et al. Adverse events in the treatment of multidrug-resistant tuberculosis: results from the DOTS-Plus initiative. Int J Tuberc Lung Dis. 2004;8(11):1382-4.
Prasad R, Singh A, Gupta N. Adverse drug reactions in tuberculosis and management. Indian J Tuberc. 2019;66(4):520-32. DOI: https://doi.org/10.1016/j.ijtb.2019.11.005
Bloss E, Kukša L, Holtz TH, et al. Adverse events related to MDR-TB treatment. Emerg Infect Dis. 2010;16(12):1923-1930.
Isaakidis P, Varghese B, Mansoor H, Cox HS, Ladomirska J, Saranchuk P, et al. Adverse events among HIV/MDR-TB co-infected patients. PLoS One. 2013;8(7):e70413. DOI: https://doi.org/10.1371/journal.pone.0040781
Pharmacovigilance Programme of India (PvPI). Indian Pharmacopoeia Commission. 2023. Available at: https://www.ipc.gov.in/images/Annual_Performa nce_Report_of_PvPI_2023-2024.pdf. Accessed on 10 November 2025.
Cegielski JP, McMurray DN. The relationship between malnutrition and tuberculosis. Int J Tuberc Lung Dis. 2004;8(3):286-98.
Lönnroth K, Williams BG, Stadlin S, Jaramillo E, Dye C. Alcohol use as a risk factor for tuberculosis - a systematic review. BMC Public Health. 2008;8:289. DOI: https://doi.org/10.1186/1471-2458-8-289
Downloads
Published
How to Cite
Issue
Section
