Safety and Tolerability of Moxifloxacin in Children.

Objectives: Moxifloxacin is not approved by the US Food and Drug Administration for pediatric use. Although its use might be indicated under certain conditions, data regarding its safety and tolerability in pediatric patients are limited. The primary objective of this study was to evaluate the safety of systemic moxifloxacin therapy in children.

Methods: We conducted a retrospective observational study of patients aged <18 years who received oral or intravenous moxifloxacin at our institution between January 2011 and July 2016. Patient demographics, clinical characteristics, indication for moxifloxacin use, and adverse events (AEs) were extracted via chart review. The attribution of AEs to moxifloxacin use was adjudicated in consultation with a pediatric infectious disease (ID) pharmacist.

Results: We identified 221 patients who received 300 courses of moxifloxacin. The average age at moxifloxacin initiation was 10.4 years. One or more AEs occurred during 195 (65%) of the courses. Of the 463 distinct AEs, 46 (9.9%) were attributed to moxifloxacin. AEs attributed to moxifloxacin included corrected QT interval (QTc) prolongation (18 [6%] courses), transaminase level elevation (7 [2.3%] courses), and increased bilirubin level (3 [1%] courses). AEs led to moxifloxacin discontinuation in 18 (6%) courses. ID consultation was associated with QTc (P < .001) and transaminase (P = .002) monitoring.

Conclusions: AEs that occur during pediatric moxifloxacin therapy are relatively common but rarely serious enough to require premature discontinuation. The drug might be used safely in most children with monitoring, including evaluation for QTc prolongation, and guidance from ID specialists.