Safety of fluoroquinolones in pediatric patients: Pharmacovigilance database analysis

Background Due to the rising prevalence of resistant bacteria, there is a growing tendency to prescribe fluoroquinolones (FQs) to pediatric patients. Real world safety parameters of FQs in children may be studied using data of national pharmacovigilance databases. The aim of our study was to estimate the structure of adverse drug reactions (ADR) associated with FQs in pediatric patients. Materials and methods retrospective study of spontaneous reports registered in Russian National Pharmacovigilance database–Automatized Information System “Pharmacovigilance” for the period: 1 April 2019–31 January 2024. Results Total number of pediatric SRs was 280 (19.2%). Mean age was 12.1 ± 5.9 years (min – 1 day, max – 18 years), and adolescents were the most involved age group ( n = 176, 62.9%). Mean time to ADR onset was 13.9 + 41.0 (min = 0, max = 303) days. Leading FQs were levofloxacin (49.6%, n = 139), ciprofloxacin (31.1%, n = 87), and moxifloxacin (15%, n = 42). Top-5 SOCs included “Immune disorders” (18.9%), “Gastrointestinal disorders” (15.0%), “Skin and subcutaneous tissue disorders” (14.7%), “General disorders and administration site conditions” (11.7%), and “Investigations” (7.6%). Top-5 PTs were urticaria, diarrhea, rash, arthralgia, and pruritus. Conclusions Levofloxacin, ciprofloxacin, and moxifloxacin were the primary FQs linked to ADRs in the pediatric population. Most prevalent were allergic reactions. Children receiving FQs should be closely monitored from the start of treatment throughout their entire hospital stay and for an extended period following discharge.