Analysis of spontaneous reports of adverse drug reactions in children of different ages

Olga A. Zhdanova; Жданова Ольга Александровна; G. A. Batishcheva; Батищев Г. А.; N. N. Perova; Перова Н. Н.; O. A. Mubarakshina; Мубаракшина О. А.; O. V. Cherenkova; Черенкова О. В.; E. D. Neyno; Нейно Е. Д.

doi:10.18565/pharmateca.2024.3.89-95

Analysis of spontaneous reports of adverse drug reactions in children of different ages

Authors: Zhdanova O.A.¹, Batishcheva G.A.¹, Perova N.N.¹^,2, Mubarakshina O.A.¹, Cherenkova O.V.¹, Neyno E.D.¹
Affiliations:
1. Voronezh State Medical University n.a. N.N. Burdenko
2. Voronezh Regional Clinical Ophthalmological Hospital
Issue: Vol 31, No 3 (2024)
Pages: 89-95
Section: Original articles
URL: https://journals.eco-vector.com/2073-4034/article/view/634929
DOI: https://doi.org/10.18565/pharmateca.2024.3.89-95
ID: 634929

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Abstract
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Abstract

Background. Issues related to the safety of medicines in children are one of the pressing problems in the healthcare sector. The anatomical and physiological characteristics of a child’s body, especially at an early age, increase the risk of developing adverse drug reactions (ADRs).

Objective. Analysis of adverse drug reactions in children in the Voronezh region in 2020–2022.

Methods. An analysis of notifications of ADRs in children submitted to the Regional Drug Safety Center of the Voronezh Region in 2020–2022 was carried out. The analysis was carried out by gender, patient age, type of reaction, severity, predictability of reactions; clinical manifestations and number of drugs, treatment and outcome of ADR were assessed. Statistical processing was carried out in Microsoft Excel (2017).

Results. The study included 97 cases of ADRs, 45 reports in children under 5 years of age, 21 reports in children aged 5 to 11 years, and 31 reports in adolescents over 11 years of age. ADRs were more often registered in children under 5 years of age (46.4%), predominantly in boys. The incidence of serious ADRs increased with the age of children from 33.3% in young children to 45.2% in adolescents. 66.0% of ADRs were type B, 31.9% were type A, and there were 2 (2.1%) cases of lack of therapeutic effect. Main clinical manifestations: allergic reactions – urticaria (35.1%), angioedema (15.5%), depression of the nervous system (9.3%), hepatotoxicity (8.2%). The predominant drug reactions were to antibacterial drugs (43.3%) and drugs for the treatment of diseases of the nervous system (19.6%). In adolescents, serious ADRs requiring drug therapy were more often reported. The outcome of ADR in 87.6% of patients was recovery or improvement.

Conclusion. It is necessary to promptly identify emerging ADRs on drugs in children to prevent the development of complications, reduce the severity of the current process, as well as to prevent long-term consequences.

Keywords

adverse drug reactions, antibacterial drugs, allergic reactions

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About the authors

Olga A. Zhdanova

Voronezh State Medical University n.a. N.N. Burdenko

Author for correspondence.
Email: olga.vr9@yandex.ru
ORCID iD: 0000-0002-3917-0395

Dr. Sci. (Med.), Associate Professor, Professor at the Department of Clinical Pharmacology

Russian Federation, Voronezh

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