PMID- 31882917 OWN - NLM STAT- MEDLINE DCOM- 20201116 LR - 20210110 IS - 2045-2322 (Electronic) IS - 2045-2322 (Linking) VI - 9 IP - 1 DP - 2019 Dec 27 TI - Real-world safety evaluation of musculoskeletal adverse events associated with Korean pediatric fluoroquinolone use: a nationwide longitudinal retrospective cohort study. PG - 20156 LID - 10.1038/s41598-019-56815-y [doi] LID - 20156 AB - Though the pediatric use of fluoroquinolones (FQs) is limited for musculoskeletal safety concerns, the clinical usefulness still exists. This study examined the association between FQs and musculoskeletal adverse events (AEs) as well as the possible risk factors associated with the pediatric FQs uses. This population-based, longitudinal, retrospective study was conducted using Korean National Sample Cohort database originating between 2002 and 2015. An FQ-treated pediatric cohort (<18 years old) was compared to a control treated with amoxicillin. Propensity score matching (PSM) and a Cox proportional hazard model was used to estimate the hazard ratio (HR) for a diagnosis of musculoskeletal AEs within 60 days of the first prescription. Among one million participants, total of 15,706 and 147,840 children were eligible for the FQ and amoxicillin cohorts, respectively. The PSM cohorts showed a slightly increased risk of musculoskeletal AEs after FQ treatment (HR, 1.19; 95% confidence interval, 1.01-1.40; p = 0.042). This association was stronger in males, older patients, and some FQs users. This study indicates that pediatric FQ use is associated with a risk of musculoskeletal AEs and that FQ use should be carefully monitored in groups with certain risk factors. Well-designed pragmatic trials could be expected to clarify these issues. FAU - Kim, Yoonhye AU - Kim Y AD - Clinical Data Analysis, Evidence based clinical research Lab., Departments of Health Science & Clinical Pharmacy, College of Pharmacy, Chung-Ang University, Seoul, 06974, Republic of Korea. FAU - Paik, Minwoo AU - Paik M AD - Clinical Data Analysis, Evidence based clinical research Lab., Departments of Health Science & Clinical Pharmacy, College of Pharmacy, Chung-Ang University, Seoul, 06974, Republic of Korea. FAU - Khan, Chanjoo AU - Khan C AD - Department of Pharmaceutical Industry, Chung-Ang University, Seoul, 06974, Republic of Korea. FAU - Kim, Yae-Jean AU - Kim YJ AD - Department of Paediatrics, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, 06351, Republic of Korea. FAU - Kim, EunYoung AU - Kim E AUID- ORCID: 0000-0003-3525-8805 AD - Clinical Data Analysis, Evidence based clinical research Lab., Departments of Health Science & Clinical Pharmacy, College of Pharmacy, Chung-Ang University, Seoul, 06974, Republic of Korea. eykimjcb777@cau.ac.kr. AD - Department of Pharmaceutical Industry, Chung-Ang University, Seoul, 06974, Republic of Korea. eykimjcb777@cau.ac.kr. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20191227 PL - England TA - Sci Rep JT - Scientific reports JID - 101563288 RN - 0 (Anti-Bacterial Agents) RN - 0 (Fluoroquinolones) SB - IM MH - Adolescent MH - Age Factors MH - Anti-Bacterial Agents/*adverse effects/therapeutic use MH - Child MH - Child, Preschool MH - Female MH - Fluoroquinolones/*adverse effects/therapeutic use MH - Humans MH - Infant MH - Longitudinal Studies MH - Male MH - Musculoskeletal Diseases/*epidemiology/*etiology MH - Proportional Hazards Models MH - Public Health Surveillance MH - Republic of Korea/epidemiology MH - Retrospective Studies MH - Risk Factors PMC - PMC6934562 COIS- The authors declare no competing interests. EDAT- 2019/12/29 06:00 MHDA- 2020/11/18 06:00 PMCR- 2019/12/27 CRDT- 2019/12/29 06:00 PHST- 2019/07/22 00:00 [received] PHST- 2019/11/30 00:00 [accepted] PHST- 2019/12/29 06:00 [entrez] PHST- 2019/12/29 06:00 [pubmed] PHST- 2020/11/18 06:00 [medline] PHST- 2019/12/27 00:00 [pmc-release] AID - 10.1038/s41598-019-56815-y [pii] AID - 56815 [pii] AID - 10.1038/s41598-019-56815-y [doi] PST - epublish SO - Sci Rep. 2019 Dec 27;9(1):20156. doi: 10.1038/s41598-019-56815-y.