Safety & Use of Ciprofloxacin

Drugs Advisory Committee constituted the scientific basis for this approval for use in adult and pediatric population. (19)

http://www.fda.gov/ohrms/dockets/ac/cder00.htm.

There is no evidence that permanent arthritis is induced by quinolone use in humans. All studies utilizing radiographic techniques, or monitoring growth and joints over long time periods have noted only rare development of transient and mild arthralgia or arthritis. Most experience is with Ciprofloxacin which therefore appears safe for use in the paediatric age group. Some data indicate safety in the neonatal period too but more and better data are required for any definitive conclusion.

WHO Pocketbook of Hospital Care for Children

Fluroquinolones are efficacious antimicrobial agents with an important role in the treatment of a variety of paediatric infections. Ciprofloxacin is a particulary useful fluorquinolone for dysentery and typhoid. There is grade A evidence to support both the overall safety of ciprofloxacin use in children and lack of joint toxicity.

1 The Capital Institute of Pediatrics, World Health Organisation Colloborative Centre, Beijing, China 2 Royal Children's Hospital, Melbourne, Australia, 2008

Analysis revealed no significant difference in elimination between younger and older children ciprofloxacin pharmacokinetic parameters in children are similar to values established in adults
Pediatric Pharmacotherapy A Monthly Review for Health Care Professionals of the Children's Medical Center Volume 4 Number 12, December 1998

Surveillance of ciprofloxacin usage in a pediatric population failed to demonstrate serious or unusually high rates of any adverse events, including joint toxicity

Pediatric Infectious Disease Journal: January 1997 - Volume 16 - Issue 1 - pp 130-134 Proceedings of a Symposium: Ciprofloxacin Use in Pediatric and Cystic Fibrosis Patients

The WHO Pocketbook of Hospital Care for Children recommends: 1. Ciprofloxacin: Oral 10-15mg/kg per dose given twice per day for five days (maximum 500mg/dose). Use in children is only warranted if the benefits outweigh the risk of arthropathy. (Pocketbook Appendix 2, pg. 333). 2. Ciprofloxacin is recommended as a suitable first line agent for the treatment of dysentery. It further recommends the possible use of ciprofloxacin for typhoid fever, but not as first line therapy. (Pocket Book Pg. 160)

Potentially, the fluoroquinolones are the most useful class of oral antibiotics for treating CSOM. Oral therapy achieves serum concentrations as high as parenteral therapy, obviating the need for intravenous delivery. Ciprofloxacin remains the most effective of the quinolones for pseudomonas. Serious consideration should be given to the use of oral fluoroquinolones when treating children with CSOM unresponsive to topical therapy.

David Parry, MD, Staff Physician, Department of Otolaryngology-Head and Neck Surgery, ENT Associates of Children's Hospital, Boston, 2009

Ciprofloxacin is a safe therapeutic option for newborns with sepsis produced by multiple resistant organisms. No osteoarticular problems or joint deformities were observed in the ciprofloxacin group during treatment or follow up. No differences in growth and development between the groups were found.

The Pediatric Infectious Disease Journal [2006, 25(12):1137-41]