RETROSPECTIVE SURVEY OF FLUOROQUINOLONE U SE IN CHILDREN

Background. - Fluoroquinolones (FQ) are contraindicated in children be cause of the risk of cartilage damage. Population and methods. - A ret rospective survey concerning the use of Fe in children during the firs t 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 prescr ibers. 83 (55.3%) were non prescribers and five (3.4%) were not able t o answer. Among the 62 prescribers of FQ, 17 departments (27%) were no r 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 trea ted with FQ. We obtained a group of 104 children aged 9.0 +/- 5.0 year s (mean +/- standard deviation [SD]), treated with 165 courses of FQ d uring 20 +/- 45 days (1-535 days) with concomitant treatments for 132/ 165 courses (80%). Fifty children (48%) were suffering from cystic fib rosis, 37 children (36%) were not, and, in 17 the diagnosis was not de termined (16%). The Fe treatment administered either orally (73%) or i ntravenously (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 m g/kg/day intravenous dose, pefloxacin in 23 courses/165 (14%) with a 1 7.2 +/- 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 i n 17 children (16%) (11 of them with cystic fibrosis). These were cuta neous events (photosensitivity, cutaneous eruption) in eight courses, rheumatologic events (arthralgia, arthritis) in seven courses and gast rointestinal events (nausea, vomiting, diarrhea) in three courses. Con clusion. - This survey shows that Fe are prescribed in children althou gh 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 in terpreting the side effects for which validity and causal assessment h ave not been worked our according to a standardized method and in the absence of a control group stress the need for a prospective study. (C ) 1998, Elsevier, Paris.