Fluoroquinolone safety in pediatric patients: a prospective, multicenter, comparative cohort study in France.

OBJECTIVE

To evaluate the safety of fluoroquinolones (FQ) in comparison with other antibiotics in pediatric patients.

METHODS

A multicenter, observational, comparative cohort study was conducted between 1998 and 2000 in French pediatric departments. Patients who were receiving systemic FQ were included and matched to control patients who were receiving other antibiotics. Antibiotic-associated potential adverse events (PAEs) were recorded prospectively in both groups, and their rates were compared using univariate and multivariate analyses.

RESULTS

Patients were recruited from 73 centers: 276 patients were exposed to FQ, and 249 composed the control group. Among patients who were exposed to FQ, 23% were younger than 2 years, 33% had cystic fibrosis, and PAEs occurred in 52 patients, leading to withdrawal for 11. The odds ratio for PAE in the FQ group was 3.7 (95% confidence interval: 1.9-7.5) and was not significantly modified after adjustment for potential confounders. Musculoskeletal PAEs also occurred more frequently in the FQ group (3.8%) than in controls (0.4%); they were recorded in 10 patients who were receiving standard FQ doses and were of moderate intensity and transient.

CONCLUSION

The rates of PAEs and musculoskeletal PAEs were higher for the FQ group than the control group. This observation supports the American Academy of Pediatrics statement restricting off-label FQ use in pediatric patients to second-line treatment in a limited number of situations.