Related Experiment Videos
Ciprofloxacin safety in a pediatric population
1Boston Collaborative Drug Surveillance Program, Boston University Medical Center, Lexington, MA 02173, USA.
Insights
Ciprofloxacin use in children showed no increased risk of serious joint, liver, or kidney problems. This study found no significant adverse events, including joint toxicity, in pediatric patients receiving ciprofloxacin.
Area of Science:
- Pediatric pharmacology
- Drug safety surveillance
- Antibiotic-associated adverse events
Background:
- Ciprofloxacin is a widely used fluoroquinolone antibiotic.
- Concerns exist regarding potential toxicities, particularly musculoskeletal, in pediatric populations.
- Limited data are available on the comprehensive safety profile of ciprofloxacin in children.
Purpose of the Study:
- To estimate the risk of musculoskeletal toxicities linked to ciprofloxacin in pediatric patients.
- To assess the incidence of hepatic and renal disorders associated with ciprofloxacin therapy in children.
- To evaluate the overall safety of ciprofloxacin in a young population.
Main Methods:
- Retrospective study design utilizing two resource databases.
- Identification of over 1700 pediatric patients (<=17 years) prescribed ciprofloxacin between 1988 and 1993.
- Adverse events were defined as those requiring physician referral or hospitalization within 45 days of prescription.
Main Results:
- No cases of newly diagnosed acute arthritis were identified as likely ciprofloxacin-induced.
- No serious liver or kidney diseases were attributed to ciprofloxacin therapy in this cohort.
- One case of hemolytic-uremic syndrome was noted, potentially exacerbated by ciprofloxacin.
Conclusions:
- Surveillance of ciprofloxacin use in pediatric patients did not reveal serious or elevated rates of adverse events.
- The study failed to demonstrate a significant risk of joint toxicity associated with ciprofloxacin in children.
- Overall, ciprofloxacin appears to have a generally favorable safety profile in the pediatric population studied.
Objective:
We conducted a retrospective study primarily to estimate the risk of musculoskeletal toxicities associated with ciprofloxacin administration in a pediatric population. In addition risks of hepatic and renal disorders associated with ciprofloxacin therapy were calculated.
Methods:
Adverse events in this study were restricted to those that required physician referral or hospitalization and occurred within 45 days of receiving a prescription for ciprofloxacin. From 2 resource databases, > 1700 patients < or = 17 years who received at least 1 ciprofloxacin prescription were identified between January, 1988, and December, 1993.
Results:
In this population there were no cases of newly diagnosed acute arthritis or serious liver or kidney disease that were likely ciprofloxacin-induced. One patient was diagnosed with hemolytic-uremic syndrome, which may have been exacerbated by ciprofloxacin therapy.
Conclusions:
Surveillance of ciprofloxacin usage in a pediatric population failed to demonstrate serious or unusually high rates of any adverse events, including joint toxicity.