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

  title={Comparative Safety Profile of Levofloxacin in 2523 Children With a Focus on Four Specific Musculoskeletal Disorders},
  author={Gary J Noel and John S Bradley and Ralph E. Kauffman and Ciar{\'a}n M. Duffy and Peter G. Gerbino and Adriano G. Arguedas and Partha Bagchi and Dainius A. Balis and Jeffrey L. Blumer},
  journal={The Pediatric Infectious Disease Journal},
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… 

Assessment of Musculoskeletal Toxicity 5 Years After Therapy With Levofloxacin

Risks of cartilage injury with levofloxacin appear to be uncommon, are clinically undetectable during 5 years, or are reversible, according to this 5-year follow-up safety study on musculoskeletal adverse events presenting between 1 and 5 years.

Fluoroquinolones in Children With Fever and Neutropenia: A Systematic Review of Prospective Trials

Fluoroquinolones can be comfortably adopted for low- risk FN, although experience in high-risk FN is uncertain in pediatrics, although reported studies have been restricted to low-risk patients.

Assessment of the risk of musculoskeletal adverse events associated with fluoroquinolone use in children

The results showed that fluoroquinolone and non-fluoroquinlone antibiotics were not different in terms of their ability to cause musculoskeletal adverse events in children.

Fluoroquinolones in pediatrics: review of hospital prescription use over 2 years.

This is the first study to collect so much data on FQ prescriptions for hospitalized children and use in practice went beyond the licensed indication, and doses were consistent with those for recommended indications.

The Risk of Musculoskeletal Adverse Events With Fluoroquinolones in Children

The purpose of this article is to examine the evidence on MAEs associated with fluoroquinolones and to provide guidance to clinicians on whether the risks of MAEs outweigh the benefits in the pediatric population.

Fluoroquinolones in children: update of the literature

Considering the increased use of FQ in children, it is possible that there is an increase in the incidence of infections from resistant germs (such as Escherichia coli, and pneumococci), as occurred in adults, and a judicious and appropriate use of this class of drugs is recommended.

Systemic use of fluoroquinolone in children

An updated review on the safety and current recommendations for using fluoroquinolones in children and how they may be particularly helpful in treating multidrug-resistant infections that have not responded to standard antibiotic therapy in immunocompromised patients is provided.

Appropriate use of fluoroquinolones in children.

Safety Concerns Surrounding Quinolone Use in Children

The pharmacological properties of fluoroquinolones are highlighted and their current use in pediatrics is described and a comprehensive assessment of the safetyData demonstrate that arthralgia and arthropathy are relatively uncommon in children and resolve following cessation of fluoquinolone exposure without resulting in long‐term sequelae.



Tendon or joint disorders in children after treatment with fluoroquinolones or azithromycin

In this observational study involving more than 6000 FQ-treated children, the incidence of TJD associated with selected FQ use in children was <1% and was comparable with that of the reference group, children treated with AZ.

Safety profile of quinolone antibiotics in the pediatric population.

  • R. Grady
  • Medicine, Biology
    The Pediatric infectious disease journal
  • 2003
A review of retrospective and prospective safety data of ciprofloxacin-treated children showed that the rates of arthralgia and quinolone-induced cartilage toxicity were low and the role of fluoroquinolones in the treatment of certain serious infections in children does not appear to be compromised by safety concerns when used appropriately.

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

The rates of PAEs and musculoskeletal PAEs were higher for the FQ group than the control group, which 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.

Safety and efficacy of gatifloxacin therapy for children with recurrent acute otitis media (AOM) and/or AOM treatment failure.

  • M. PichicheroA. Arguedas R. Echols
  • Medicine, Biology
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
  • 2005
Gatifloxacin appears to be safe for children, with no evidence of producing arthrotoxicity in 867 children exposed to the antibiotic when used as treatment for ROM and AOMTF.

An Open-Label, Double Tympanocentesis Study of Levofloxacin Therapy in Children With, or at High Risk for, Recurrent or Persistent Acute Otitis Media

Levofloxacin was safe and effective in treating and eradicating common bacterial pathogens from MEF in children with, or at risk for, recurrent or persistent otitis media.

Levofloxacin Pharmacokinetics in Children

To provide compatible levofloxacin exposures associated with clinical effectiveness and safety in adults, children <5 years need a daily dose of 10 mg/kg, whereas children 6 months to<5 years should receive 10mg/kg every 12 hours.

Open label, multicenter study of gatifloxacin treatment of recurrent otitis media and acute otitis media treatment failure

Gatifloxacin is safe and effective for treatment of recurrent otitis media and AOM treatment failure in children, and eighty-three percent of the children had sustained cure at the 4 weeks follow-up visit.

Pediatric urinary tract infections: the role of fluoroquinolones

Oral fluoroquinolones are an attractive alternative for the treatment of complicated UTI in children, and safety must always be a factor in considering their use in this population.

Quinolone arthropathy in animals versus children.

The use of quinolones in children and accumulation of data on the pharmacodynamics of these drugs have been limited and delayed by concern regarding their chondrotoxicity. A comprehensive review of

Levofloxacin and trovafloxacin: the next generation of fluoroquinolones?

  • M. E. ErnstE. ErnstM. Klepser
  • Medicine, Biology
    American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
  • 1997
Levofloxacin and trovafloxACin have favorable antimicrobial and pharmacokinetic profiles, offering the advantages of once-daily doses as well as superior potency and spectrum of activity compared with currently available quinolones.