The incidence of collagen-associated adverse events in pediatric population with the use of Fluoroquinolones: a nationwide cohort study in Taiwan
Abstract
Abstract Background: To evaluate the safety of using fluoroquinolones (FQs) in pediatric population in Taiwan.Methods: Patients aged 0~18-year-old with FQs prescriptions ≥3 consecutive days during year 2000 to 2013 were selected from the National Health Insurance Research Database, 4-time case number were selected as controls. We evaluated the patient’s outcome after the use of FQs by reviewing a newly diagnosis of the following collagen-associated adverse events by ICD-9-CM codes, covering tendons rupture, retinal detachments, gastrointestinal tract perforation, aortic aneurysm or dissection.Results: Of the enrolled patients (n=167,105), collagen-associated adverse effects developed in 85 cases (0.051%) in 6-month tracking, including 0.051% in the FQs study cohort (17 in 33,421) and 0.051% (68 in 133,684) in the FQs free comparison cohort. The crude HR for collagen-associated adverse events in the FQs group was 0.997 (0.586-1.696; p=0.990). After adjusting for age, sex, catastrophic illness, low-income household, seasons, levels of urbanization, and healthcare, the corrected HR in 6-month tracking with FQs was 1.360 (95% CI; 0.795-2.326; p=0.261).Conclusions: There is no significant difference of collagen-associated adverse effects between FQs group and FQs free group from our data. We propose that FQs for pediatric population in clinical practice may be not so harmful as previous references reported.
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 167,105 participants or records.
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