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Background:

Fluoroquinolones, including levofloxacin, have not been recommended for use in children largely because studies in juvenile laboratory animals suggest there may be an increased risk of fluoroquinolone-associated cartilage lesions. A large prospective trial is needed to assess the risks associated with using levofloxacin in children.

Objective:

Assess the safety and tolerability of levofloxacin therapy in children based on observations for 1 year after therapy.

Methods:

Safety data were collected in children who participated in 1 of 3 efficacy trials (N= 2523) and a subset of these children who also subsequently participated in a long-term 1-year surveillance trial (N= 2233). Incidence of adverse events in children randomized to receive levofloxacin versus nonfluoroquinolone antibiotics was compared. Based on assessments by treating physicians and an independent data safety monitoring committee, events …