Comparative Safety Profile of Levofloxacin in 2523 Children With a Focus on Four Specific Musculoskeletal Disorders

Abstract

The incidence of 1 or more of the 4 predefined musculoskeletal disorders identified in nonblinded, prospective evaluations, was statistically greater in levofloxacin-treated compared with comparator-treated children.

Consensus Guidelines for the Prevention and Treatment of Catheter-Related Infections and Peritonitis in Pediatric Patients Receiving Peritoneal Dialysis: 2012 Update

“…As noted earlier (211)(212)(213)(214). The use of ciprofloxacin monotherapy can be complicated by the development of antibiotic resistance.…”

“…Fluoroquinolones (for example, ciprofloxacin) can be used to treat Pseudomonas peritonitis. Fluoroquinolones have been used extensively in pediatrics, and as noted earlier, experimental data in humans have not substantiated the cartilage damage that was observed in beagle puppies (211,212 Multidrug-resistant gram-negative bacteria have emerged as important pathogens in many health care-related infections. Notably, many gram-negative bacteria have developed the ability to inactivate third-generation cephalosporins such as cefotaxime, ceftriaxone, and ceftazidime through various mechanisms, including production of ESBLs.…”

The Use of Systemic and Topical Fluoroquinolones

“…Data were collected from a community-acquired pneumonia trial in children 6 months to 16 years of age (a randomized 3:1, prospective, comparative trial in 533 levofloxacin-exposed and 179 comparator-exposed evaluable subjects) and from 2 trials assessing therapy for acute otitis media in children 6 months to 5 years of age (1 open-label noncomparative study in 204 evaluable subjects and another randomized 1:1, prospective, comparative trial in 797 levofloxacin-exposed and 810 comparator-exposed evaluable subjects). 13 In addition, after completion of the treatment trials, all subjects from both treatment arms were also offered participation in an unblinded, 12-month follow-up study for safety assessments, including musculoskeletal events.…”

Pharmacometrics-Based Dose Selection of Levofloxacin as a Treatment for Postexposure Inhalational Anthrax in Children

“…regimen for children older than 5 years exceeded the exposure associated with dosing regimens of 10 mg/kg q.d. that were studied in a clinical trial involving children with community-acquired pneumonia (3,8). Furthermore, there is no prospective clinical trial experience that has defined the safety and tolerability of levofloxacin used in children for more than 14 days.…”