Pharmacovigilance in pediatrics: adverse drug reactions in the use of antibacterial medicines for systemic use among children for the period of 2018-2022

According to the WHO, antibacterial drugs for systemic use most often lead to adverse drug reactions, namely contribute to approximately 23% of all adverse events reported in the world. Children are more at risk of adverse drug reactions because a significant number of drugs prescribed in this population enter the market with limited experience in clinical trials of their efficiency and safety. The aim of the work was to determine the main trends in the development of adverse reactions to antibacterial medicines for systemic use among children for the period 2018–2022. The object of the study was notification cards on adverse reactions of medicines. In the course of the study, the following methods were applied: spontaneous messages and methods of statistical data processing. A general analysis of the identified adverse reactions allows us to identify the following trends that were characteristic of each year of follow-up. In particular, it was found that the most common manifestations of adverse reactions to antibacterial drugs are skin rashes (39–51%), dyspeptic disorders (13–26%), hyperemia at the injection site (7–17%), urticaria-type rash (8–9%), headache and fever (3–4%). All these manifestations of adverse reactions belong to category B (dose-independent), due to the immunological characteristics of the child in response to the administration of the drug (active and excipients). Among the adverse reactions observed during this period, the following were distributed in terms of severity: fatal cases (2 reports in 2018); severe (anaphylactic shock from 4 cases in 2018 to 13 cases in 2019); moderate severity (urticaria, angioedema, an average of 4 to 13 cases per year). According to the results of our scientific study, 3 053 report cards on cases of adverse reactions of antibacterial medicines for systemic use were analyzed. It has been found that in Ukraine, after the use of systemic antibacterial medicines, adverse reactions such as skin rashes and gastrointestinal adverse reactions (dyspeptic disorders) are three times less common in children, while in other countries (Brazil, USA), on the contrary, the latter are more common.