PMID- 29939314 OWN - NLM STAT- MEDLINE DCOM- 20181113 LR - 20220409 IS - 2048-7207 (Electronic) IS - 2048-7193 (Linking) VI - 7 IP - 3 DP - 2018 Aug 17 TI - Safety and Tolerability of Moxifloxacin in Children. PG - e92-e101 LID - 10.1093/jpids/piy056 [doi] AB - OBJECTIVES: Moxifloxacin is not approved by the US Food and Drug Administration for pediatric use. Although its use might be indicated under certain conditions, data regarding its safety and tolerability in pediatric patients are limited. The primary objective of this study was to evaluate the safety of systemic moxifloxacin therapy in children. METHODS: We conducted a retrospective observational study of patients aged <18 years who received oral or intravenous moxifloxacin at our institution between January 2011 and July 2016. Patient demographics, clinical characteristics, indication for moxifloxacin use, and adverse events (AEs) were extracted via chart review. The attribution of AEs to moxifloxacin use was adjudicated in consultation with a pediatric infectious disease (ID) pharmacist. RESULTS: We identified 221 patients who received 300 courses of moxifloxacin. The average age at moxifloxacin initiation was 10.4 years. One or more AEs occurred during 195 (65%) of the courses. Of the 463 distinct AEs, 46 (9.9%) were attributed to moxifloxacin. AEs attributed to moxifloxacin included corrected QT interval (QTc) prolongation (18 [6%] courses), transaminase level elevation (7 [2.3%] courses), and increased bilirubin level (3 [1%] courses). AEs led to moxifloxacin discontinuation in 18 (6%) courses. ID consultation was associated with QTc (P < .001) and transaminase (P = .002) monitoring. CONCLUSIONS: AEs that occur during pediatric moxifloxacin therapy are relatively common but rarely serious enough to require premature discontinuation. The drug might be used safely in most children with monitoring, including evaluation for QTc prolongation, and guidance from ID specialists. FAU - Dixit, Avika AU - Dixit A AD - Division of Infectious Diseases, Boston Children's Hospital, Massachusetts. AD - Harvard Medical School, Boston, Massachusetts. FAU - Karandikar, Manjiree V AU - Karandikar MV AD - Division of Infectious Diseases, Boston Children's Hospital, Massachusetts. AD - Harvard Medical School, Boston, Massachusetts. FAU - Jones, Sarah AU - Jones S AD - Division of Infectious Diseases, Boston Children's Hospital, Massachusetts. AD - Department of Pharmacy, Boston Children's Hospital, Massachusetts. FAU - Nakamura, Mari M AU - Nakamura MM AD - Division of Infectious Diseases, Boston Children's Hospital, Massachusetts. AD - Harvard Medical School, Boston, Massachusetts. AD - Division of General Pediatrics, Boston Children's Hospital, Massachusetts. LA - eng PT - Journal Article PT - Observational Study PL - England TA - J Pediatric Infect Dis Soc JT - Journal of the Pediatric Infectious Diseases Society JID - 101586049 RN - 0 (Anti-Bacterial Agents) RN - 0 (Fluoroquinolones) RN - EC 2.6.1.1 (Aspartate Aminotransferases) RN - EC 2.6.1.2 (Alanine Transaminase) RN - RFM9X3LJ49 (Bilirubin) RN - U188XYD42P (Moxifloxacin) SB - IM MH - Administration, Intravenous MH - Administration, Oral MH - Adolescent MH - Alanine Transaminase/blood/drug effects MH - Anti-Bacterial Agents/*adverse effects/*therapeutic use MH - Aspartate Aminotransferases/blood/drug effects MH - Bacterial Infections/blood/*drug therapy/enzymology MH - Bilirubin/blood MH - Blood Cell Count MH - Child MH - Child, Preschool MH - Drug Administration Schedule MH - Female MH - Fluoroquinolones/*adverse effects/*therapeutic use MH - Humans MH - Infant MH - Long QT Syndrome/chemically induced MH - Male MH - Moxifloxacin MH - Neutropenia/chemically induced MH - Retrospective Studies MH - Seizures/chemically induced EDAT- 2018/06/26 06:00 MHDA- 2018/11/14 06:00 CRDT- 2018/06/26 06:00 PHST- 2018/01/11 00:00 [received] PHST- 2018/06/07 00:00 [accepted] PHST- 2018/06/26 06:00 [pubmed] PHST- 2018/11/14 06:00 [medline] PHST- 2018/06/26 06:00 [entrez] AID - 5043489 [pii] AID - 10.1093/jpids/piy056 [doi] PST - ppublish SO - J Pediatric Infect Dis Soc. 2018 Aug 17;7(3):e92-e101. doi: 10.1093/jpids/piy056.