REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot162410.32687/1561-5936-2023-27-2-118-122Original ArticleMonitoring information on the safety of antibacterial and anti-tuberculosis drugsEgiazaryanElizaveta A.001KosovaIrina V.002Peoples’ Friendship University of Russia, Moscow, Russia15122023211812210102025Copyright © 2023,2023The study was conducted to identify cases of adverse drug reactions, the frequency and nature of adverse reactions associated with the use of antibacterial drugs: abacavir, azithromycin, levofloxacin, linezolid, metronidazole moxifloxacin, cefoperazone + sulbactam, cefepime + sulbactam and anti-tuberculosis drugs: isoniazid, pyrazinamide, ethambutol. Given the clinical significance of antibacterial and anti-tuberculosis drugs, it is necessary to take seriously the study of the risks associated with therapy. Since antibacterial drugs lead in the number of ADRs that occur, and tuberculosis is a socio-economic burden and remains in the list of the main causes of death worldwide, complications after the use of anti-tuberculosis and antibacterial drugs in the post-registration period are an urgent problem.adverse drug reactionspost-registration studiesantibacterial drugsanti-tuberculosis drugssafety profilepharmacovigilanceнежелательные лекарственные реакциипострегистрационные исследованияантибактериальные препаратыпротивотуберкулёзные препаратыпрофиль безопасностифармаконадзор[Nikolaeva T. N., Romanova S. V., Romanov B. K., Aljautdin R. N. Analysis of data on the safety of clinical trials in Russia in 2012—2016. Medical ethics. 2017; 5(1): 60—62. (In Russ.)][Demchenkova E. Yu., Gorodeckaya G. I., Mazerkina I. A. et al. Topical issues of detection and monitoring of adverse reactions in the use of cephalosporin antibiotics. Safety and risk of pharmacotherapy. 2021; 9(1): 34—42. (In Russ.) doi: 10.30895/2312-7821-2021-9-1-34-42][Borovikova E. A. Problems of reporting cases of adverse drug reactions by medical and pharmaceutical workers. In: Production of domestic medicines and pharmaceutical education: key trends of interaction: materials of the VII All-Russian Scientific and Practical Conference. Moscow, December 18, 2020. Moscow; 2020:15—24. (In Russ.)][Maevskaya V. A., Gorelov K. V., Korzina N. S., Stromova A. S. Pharmacovigilance in the Yaroslavl region on the example of antibacterial drugs. Vestnik VolgGMU. 2021; (2): 169—176. (In Russ.) doi: 10.19163/1994-9480-2021-2(78)-169-176][Shubnikova E. V., Darmostukova M. A., Bukatina T. M. et al. About the adverse drug reactions registered in the post-marketing period. Safety and risk of pharmacotherapy. 2019; 7(1): 15—22. (In Russ.)][Verlan N. V., Kochkina E. O., Popadjuk A. V. Experience in drug safety monitoring in geriatric practice. Bulletin VSNCSO RAMN. 2016; 1(2): P. 35—38. (In Russ.)][Belousov Yu. B., Leonova M. V. Features of the use of the drug in geriatric practice. Pharmateka. 2008; (8): 13—19. (In Russ.)][Dvoynikova N. A., Verlan N. V., Kochkina E. O. et al. Technology for drug safety monitoring in clinical practice. Siberian Medical Journal. 2014; (6): 103—105. (In Russ.)][Titova A. R., Pasternak E. Yu., Aseckaya I. L. et al. On the safety of antibacterial drugs used in pediatrics. Safety and risk of pharmacotherapy. 2015; (2): 12—22. (In Russ.)][Kuz'mina A.V., Polivanov V. A., Aseckaya I. L., Zyryanov S. K. Safety issues in the use of antibacterial drugs in clinical practice. Clinical microbiology. 2015; 17(2): 146—156. (In Russ.)][Savchenko A. Yu., Ramenskaja G. V., Kukes V. G. et al. Evaluation of the safety of a new anti-tuberculosis drug in silico and in healthy volunteers. Pharmacogenetics and pharmacogenomics. 2021; (1): 42—47. (In Russ.)][Demchenkova E. Yu., Gorodeckaya G. I., Mazerkina I. A. et al. Topical issues of detection and monitoring of adverse reactions in the use of cephalosporin antibiotics. Safety and risk of pharmacotherapy. 2021; 9(1): 34—42. (In Russ.)][Sinopal'nikov A.I., Andreeva I. V., Stecjuk O. U. Safety of macrolide antibiotics: a critical analysis. Clinical medicine. 2012; 90(3): 23—30. (In Russ.)][Baldi E., Rordorf R., Masiello L. et al. QTc prolongation and mortality in SARS-2-CoV-infected patients treated with azithromycin and hydroxychloroquine. J. Cardiovasc. Med. (Hagerstown). 2022; 23(1): e21—e23. doi: 10.2459/JCM.0000000000001238][Ostroumova O. D., Pereverzev A. P., Pavleeva E. E., Romanovskiy R. R. Antibiotic-associated drug-induced liver injury with cholestasis: actualization of the problem in the era of COVID-19. Medical alphabet. 2021; (1): 31—43. (In Russ.)][Karoli N. A., Rebrov A. P. Antibiotic-associated drug-induced liver injury with cholestasis: actualization of the problem in the era of COVID-19. Therapy. 2016; (4): 92-101;][Benjelloun R., Otheman Y., El Kettani C. Psychiatric side effects of chloroquine in COVID-19 patients: two case reports. Pan. Afr. Med. J. 2020; 35(Suppl 2): 83. doi: 10.11604/pamj.supp.2020.35.24064][Ando N., Nishijima T., Mizushima D. et al. Long-term weight gain after initiating combination antiretroviral therapy in treatment-naïve Asian people living with human immunodeficiency virus. Int. J. Infect. Dis. 2021; 110: 21—28. doi: 10.1016/j.ijid.2021.07.030][Monitoring of foreign drug safety information. Safety and Risk of Pharmacotherapy. 2019; 7(4): 221—226. doi: 10.30895/2312-7821-2019-7-4-221-226][O'Connor C., Brady M. F. Isoniazid. StatPearls. Treasure Island; 2022.][Boopathi D., Akshatha J. S., Uma Buggi et al. Prolonged isoniazid-induced psychosis in a patient on dots therapy — a case report. Res. J. Pharm. Technol. 2020;13(11):5267—5269.][Saxena R., Singh D., Phuljhele S. et al. Ethambutol toxicity: expert panel consensus for the primary prevention, diagnosis and management of ethambutol-induced optic neuropathy. Ind. J. Ophthalmol. 2021;69(12):3734—3739. doi: 10.4103/ijo.IJO_3746_20][Matsumoto T., Kusabiraki R., Arisawa A. et al. Drastically progressive ethambutol-induced optic neuropathy after withdrawal of ethambutol: a case report and literature review. Intern. Med. 2021;60(11):1785—1788. doi: 10.2169/internalmedicine.6178-20]