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Ciprofloxacin in pediatrics: worldwide clinical experience based on compassionate use--safety report
B Hampel1, R Hullmann, H Schmidt
1Bayer AG, Wuppertal, Germany.
Insights
Ciprofloxacin use in children showed low rates of reversible joint pain, similar to adult safety profiles. This suggests ciprofloxacin (a fluoroquinolone antibiotic) is safe for pediatric use, even in those with cystic fibrosis.
Area of Science:
- Pediatric Pharmacology
- Antimicrobial Safety
- Clinical Toxicology
Background:
- Fluoroquinolones are contraindicated in children due to potential cartilage toxicity observed in juvenile animal studies.
- Previous studies indicated low rates of reversible arthralgia and a similar safety profile to adults in children receiving ciprofloxacin.
- Species- and dose-specific toxicity necessitates careful evaluation of fluoroquinolone use in pediatric populations.
Purpose of the Study:
- To evaluate the safety and adverse event profile of ciprofloxacin in a large cohort of pediatric patients.
- To assess the incidence and characteristics of arthralgia associated with ciprofloxacin treatment in children.
- To compare the safety findings in children with previously established data in adult populations.
Main Methods:
- Retrospective analysis of 1795 children receiving 2030 treatment courses of intravenous or oral ciprofloxacin.
- Data collection on treatment-associated events, specifically arthralgia, including severity and resolution.
- Comparison of adverse event rates between oral and intravenous administration and with historical data.
Main Results:
- Overall arthralgia occurred in 1.5% of ciprofloxacin treatment courses, predominantly mild to moderate and self-resolving.
- Children with cystic fibrosis accounted for over 60% of arthralgia episodes.
- Treatment-associated events were reported in 10.9% of oral ciprofloxacin recipients versus 18.9% of intravenous recipients.
Conclusions:
- The safety profile of ciprofloxacin in children is comparable to that observed in adult patients.
- Rates of reversible arthralgia were low and consistent with prior surveillance data in pediatric populations.
- Ciprofloxacin demonstrates an acceptable safety profile for use in children, including those with cystic fibrosis.
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.