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 in pediatric population in Taiwan. Methods : Patients aged 0~18 years old with fluoroquinolones prescriptions ≥5 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 fluoroquinolones by reviewing a newly diagnosis of the following collagen-associated adverse events by International Classification of Diseases, Ninth Revision, Clinical Modification 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 fluoroquinolones study cohort (17 in 33,421) and 0.051% (68 in 133,684) in the fluoroquinolones free comparison cohort. The crude hazard ratio for collagen-associated adverse events in the fluoroquinolones 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 hazard ratio in 6-month tracking with FQs was 1.330 (95% CI; 0.778-2.276; p=0.255). Conclusions: There is no significant difference of collagen-associated adverse effects between fluoroquinolones group and fluoroquinolones free group from our data. We propose…
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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