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[Retrospective survey of fluoroquinolone use in children]
A Pariente-Khayat1, F Vauzelle-Kervroedan, P d'Athis
1Département de pharmacologie périnatale et pédiatrique, hôpital Saint-Vincent-de-Paul, université René-Descartes, Paris, France.
Insights
Fluoroquinolones (FQ) are prescribed to children despite risks, with many experiencing side effects like skin and joint issues. Further prospective studies are needed to fully understand FQ safety in pediatric populations.
Area of Science:
- Pediatric pharmacology
- Infectious disease management
- Drug safety surveillance
Context:
- Fluoroquinolones (FQ) are generally contraindicated in pediatric patients due to potential cartilage damage.
- Despite contraindications, FQ are sometimes used in children for various infections.
Purpose:
- To assess the current prescribing practices of fluoroquinolones in children.
- To identify the frequency and types of adverse events associated with FQ use in pediatric patients.
Summary:
- A retrospective survey of 167 pediatric departments revealed that 41.3% prescribed FQ to children.
- 104 children received 165 courses of FQ, primarily ciprofloxacin, for conditions including cystic fibrosis.
- 16% of treated children experienced adverse events, including cutaneous and rheumatologic issues.
Impact:
- Highlights the off-label use of FQ in pediatrics and associated adverse events.
- Underscores the need for more rigorous, prospective studies to establish safety and efficacy in children.
- Informs clinical practice regarding the risks and benefits of FQ in pediatric populations.
Background:
Fluoroquinolones (FQ) are contraindicated in children because of the risk of cartilage damage.
Population And Methods:
A retrospective survey concerning the use of FQ in children during the first 6 months of 1993 was organized in 1994. One hundred and sixty-seven Heads of pediatric departments were questioned.
Results:
One hundred and fifty (90%) of those surveyed responded: 62 (41.3%) were FQ prescribers, 83 (55.3%) were non prescribers and five (3.4%) were not able to answer. Among the 62 prescribers of FQ, 17 departments (27%) were not able to indicate the number of prescriptions and 45 departments (73%) reported one to 75 prescriptions during the study period. Twenty-one departments out of the 45 were not able to identify the children treated with FQ. We obtained a group of 104 children aged 9.0 +/- 5.0 years (mean +/- standard deviation [SD]), treated with 165 courses of FQ during 20 +/- 45 days (1-535 days) with concomitant treatments for 132/165 courses (80%). Fifty children (48%) were suffering from cystic fibrosis, 37 children (36%) were not, and, in 17, the diagnosis was not determined (16%). The FQ treatment administered either orally (73%) or intravenously (26%) was ciprofloxacin in 69% of the courses with a 25.1 +/- 7.0 mg/kg/day oral dose (mean +/- SD dose), and a 23.5 +/- 11.4 mg/kg/day intravenous dose, pefloxacin in 23 courses/165 (14%) with a 17.2 +/- 3.8 mg/kg/day dose, ofloxacin in 15 courses/165 (9%) with a 21.0 +/- 11.9 mg/kg/day dose, norfloxacin in 13 courses/165 (8%) with a 25.6 +/- 7.5 mg/kg/day dose. Twenty-one adverse events were reported in 17 children (16%) (11 of them with cystic fibrosis). These were cutaneous events (photosensitivity, cutaneous eruption) in eight courses, rheumatologic events (arthralgia, arthritis) in seven courses and gastrointestinal events (nausea, vomiting, diarrhea) in three courses.
Conclusion:
This survey shows that FQ are prescribed in children although their use is not approved in this age group and that numerous side effects have been recorded. The absence of exhaustive information (due to the retrospective nature of the survey) and the difficulties in interpreting the side effects for which validity and causal assessment have not been worked out according to a standardized method and in the absence of a control group stress the need for a prospective study.