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

Chuen L Yee1, Ciaran Duffy, Peter G Gerbino

  • 1Johnson & Johnson Pharmaceutical Research and Development, L.L.C., Raritan, NJ 08869, USA.

The Pediatric Infectious Disease Journal
|August 17, 2002
PubMed

Insights

Fluoroquinolone (FQ) antibiotics showed a low incidence of tendon or joint disorders (TJDs) in children, comparable to azithromycin. This study suggests FQs may be safely used in pediatric patients regarding TJD risk.

Area of Science:

  • Pediatric pharmacology
  • Infectious disease research
  • Clinical safety studies

Background:

  • Fluoroquinolones (FQs) use in children is limited due to animal studies showing cartilage lesions.
  • The clinical relevance of these animal findings in pediatric patients remains unclear.
  • Azithromycin (AZ) serves as a control due to its established safety profile regarding cartilage and tendons.

Purpose of the Study:

  • To evaluate the incidence and relative risk of tendon or joint disorders (TJDs) in children treated with specific FQs.
  • To compare TJD rates between children receiving ofloxacin (OFX) or ciprofloxacin (CPX) and those receiving azithromycin (AZ).

Main Methods:

  • Retrospective observational study utilizing an automated database.
  • Identified pediatric patients (<19 years) prescribed OFX, levofloxacin, ciprofloxacin (CPX), or AZ.
  • Verified TJD cases within 60 days of prescription through blinded medical record review.

Main Results:

  • The incidence of verified TJDs was low (<1%) for both OFX (0.82%) and CPX (0.82%) compared to AZ (0.78%).
  • Relative risk of TJD for OFX and CPX versus AZ was approximately 1.04, indicating comparable risk.
  • Joint disorders were the most frequent TJD category, followed by tendon, cartilage, and gait disorders.

Conclusions:

  • Selected fluoroquinolone use in over 6000 children was associated with a low incidence of TJDs (<1%).
  • The risk of TJDs with OFX and CPX was comparable to that observed with azithromycin.
  • These findings suggest that the concern for FQ-associated TJDs in children may be overstated.
Abstract

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