Safety profile of ciprofloxacin in the pediatric population: analysis of the database of spontaneous reports
https://doi.org/10.37489/2588-0519-GCP-0005
EDN: KWFHYD
Abstract
Background. Fluoroquinolones (FQs) are a group of antibacterial drugs (AB), and their consumption is increasing in both the general and pediatric populations. The main FQ prescribed in pediatrics is ciprofloxacin, which is used in patients with cystic fibrosis, oncology, and severe multidrug-resistant infections. The potential toxic effects of ciprofloxacin on various organs and systems (e.g., musculoskeletal, nervous, and cardiovascular systems) highlight the importance of monitoring the real-world safety of this FQ in children.
Objective. The safety profile of ciprofloxacin in children was assessed using the National Spontaneous Reporting Database.
Methods. Retrospective pharmacoepidemiologic study of spontaneous reports (SRs) received in the Pharmacovigilance 2.0 subsystem of the Automated Information System (AIS) of Roszdravnadzor from 01.04.2019 to 01.03.2023.
Results. Most adverse reactions (ADRs) developed within the first 24 h (43.3%) after the AB prescription. Most ADRs were registered in male patients (73,2%). The most involved age groups were 0–1 year (31,7%) and 10–15 years (36,6%). Immune system disorders (31.3%) were the leading cause of ADRs.
Conclusion. The identified ADR profile of ciprofloxacin indicates the need for rational restriction of the use of this AB in the pediatric population; if it is impossible to replace it with another AB with a similar spectrum of activity, constant monitoring of symptoms of adverse reactions is recommended, which is especially important in the population of children under one year of age.
About the Authors
O. I. Butranova
Peoples' Friendship University of Russia named after Patrice Lumumba
Russian Federation
Competing Interests:
Russian Federation
Olga I. Butranova — Cand. Sci. (Med.), Associate Professor of the Department of General and Clinical Pharmacology
Moscow
Competing Interests:
The authors declare no conflict of interest.
Yu. O. Kustov
Peoples' Friendship University of Russia named after Patrice Lumumba
Russian Federation
Competing Interests:
Russian Federation
Yuri O. Kustov — 2nd-year postgraduate student at the Department of General and Clinical Pharmacology
Moscow
Competing Interests:
The authors declare no conflict of interest.
S. K. Zyryanov
Peoples' Friendship University of Russia named after Patrice Lumumba
Russian Federation
Competing Interests:
Russian Federation
Sergey K. Zyryanov — Dr. Sci. (Med.), Professor, Head of the Department of General and Clinical Pharmacology
Moscow
Competing Interests:
The authors declare no conflict of interest.
I. L. Asetskaya
Peoples' Friendship University of Russia named after Patrice Lumumba
Russian Federation
Competing Interests:
Russian Federation
Irina L. Asetskaya — Cand. Sci. (Med.), Associate Professor of the Department of General and Clinical Pharmacology
Moscow
Competing Interests:
The authors declare no conflict of interest.
E. N. Terekhina
Peoples' Friendship University of Russia named after Patrice Lumumba ; Roszdravnadzor Information and Methodological Center for Examination, Accounting, and Analysis of the Circulation of Medical Products
Russian Federation
Competing Interests:
Russian Federation
Elizaveta N. Terekhina — Assistant Professor of the Department of General and Clinical Pharmacology
Moscow
Competing Interests:
The authors declare no conflict of interest.
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Review
For citations:
Butranova O.I., Kustov Yu.O., Zyryanov S.K., Asetskaya I.L., Terekhina E.N. Safety profile of ciprofloxacin in the pediatric population: analysis of the database of spontaneous reports. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2025;(4):55-64. (In Russ.) https://doi.org/10.37489/2588-0519-GCP-0005. EDN: KWFHYD
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