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. Author manuscript; available in PMC: 2017 Sep 1.
Published in final edited form as: J Clin Pharmacol. 2016 Mar 28;56(9):1060–1075. doi: 10.1002/jcph.715

Table 6.

Studies With Outcome Data on Fluoroquinolone-Associated Musculoskeletal Events in Neonates

First Author and
Reference		 Study Design No. Tx
With
FLQ/Total		 Age FLQ Indication FLQ Duration
of FLQ
Exposure		 Duration of
Follow-Up		 Description of Adverse Events
Lumbiganon 1991117 Follow-up study 11 Neonates >26 weeks Nosocomial Klebsiella infections Ciprofloxacin 10–20 days 12–23 months Normal growth and development. No skeletal dysfunction or joint abnormalities. Greenish teeth discoloration was noted in two patients.
Martell 1996118 Longitudinal study 7/21 Mean 32 weeks Clinical sepsis Ciprofloxacin, Pefloxacin 10 days 42 months No osteoarticular sequelae or joint deformities. No growth impairment noted with fluoroquinolone treatment.
Gurpinar 1997119 Longitudinal comparative survey 9/27 Mean 35 weeks Clinical sepsis Ciprofloxacin 14 days 42 months No osteoarticular sequelae or joint deformities. No growth impairment noted with fluoroquinolone treatment.
Belet 2004120 Prospective study 30 25–38 weeks Nosocomial P aeruginosa infections Ciprofloxacin 8–24 days 1 week post-discharge No evidence of joint toxicity.
Chaudhari 2004121 Prospective case-matched control study 30/60 Mean 33.2 ± 3.83 weeks Neonatal septicemia Ciprofloxacin 14 days 6 months No effects on growing cartilage or joint involvement confirmed by ultrasound.
Drossou-Agakidou 2004122 Observational prospective matched study 77/160 25–40 weeks Clinical sepsis Ciprofloxacin 14 days 12 months No evidence of articular damage or growth impairment.
Ahmed 2006123 Prospective cohort study 48/114 <33 weeks Life-saving therapy in sepsis Ciprofloxacin 15.4 ± 10.6 days 24.7 ± 18.5 months No evidence of acute or subclinical joint toxicity. Growth and development were normal.
Dutta 2006124 Retrospective cohort study 61/205 <37 weeks Various ne onatal infections Ciprofloxacin >3 days 12 months No effect on linear growth.
Kaguelidou 201181 Systematic literature review 451/1256 <4 weeks Neonatal infections Ciprofloxacin 5–75 days 1 week–36 months No serious adverse events, including joint toxicity, observed.

FLQ, fluoroquinolone.