Related Experiment Videos
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.
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.
Background:
Fluoroquinolones (FQs) have been infrequently used in children, largely because of concern that these agents can cause lesions of the cartilage in juvenile animals. However, the relevance of this laboratory observation to children treated with FQs is unknown. A retrospective, observational study was conducted to assess the incidence and relative risk of tendon or joint disorders (TJDs) that occur after use of selected FQs compared with azithromycin (AZ), a drug with no known effect on cartilage or tendons in humans or animals.
Methods:
An automated database was searched to identify patients younger than 19 years who had been prescribed ofloxacin (OFX), levofloxacin, ciprofloxacin (CPX), or AZ. Potential cases of TJD occurring within 60 days of a prescription of one of the study drugs were identified based on assignment of a claims diagnosis consistent with a TJD within this period. Verified cases were identified by a blinded review of abstracts of medical records from subjects identified as potential cases.
Results:
The incidence of verified TJD was 0.82% for OFX (13 of 1593) and CPX (37 of 4531) and was 0.78% for AZ (118 of 15,073). The relative risk of TJD for OFX and CPX compared with AZ was 1.04 (95% confidence interval, 0.55 to 1.84) and 1.04 (95% confidence interval, 0.72 to 1.51), respectively. The distributions of claims diagnoses and time to onset of TJD were comparable for all groups. The most frequently reported category of TJD involved the joint followed by tendon, cartilage and gait disorder.
Conclusions:
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.