Ciprofloxacin in pediatrics: Worldwide clinical experience based on compassionate use - Safety report

Background. Quinolone-induced cartilage toxicity has been observed in experimental juvenile animal studies and is species- and dose-specific. Accordingly these findings have led to the contraindication of fluoroquinolones in children. Previous data in 634 adolescents and children treated with compassionate use ciprofloxacin demonstrated low rates of reversible arthralgia and a safety profile similar to that for adult patients. Objective. This report describes the safety findings in 1795 children who received 2030 treatment courses of intravenous or oral ciprofloxacin. Results. The average doses of intravenous and oral ciprofloxacin in the study population were 8 and 25 mg/kg/day, respectively. Treatment-associated events were reported in 10.9% of children receiving oral ciprofloxacin compared with 18.9% among intravenous recipients. Overall arthralgia occurred during 31 ciprofloxacin treatment courses (1.5%) and the majority of events were of mild to moderate severity and resolved without intervention. More than 60% of arthralgia episodes were in children with cystic fibrosis. Conclusion. The adverse event pattern in children receiving ciprofloxacin in this analysis was similar to that observed in adults. Rates of reversible arthralgia were low and unchanged from previously published surveillance data in children.