Abstract
Systemic antibiotics are the group of drugs most commonly used in children. Off-label antibiotic use in children is still common in the community and in hospitals, mostly because of young age, dosage, or frequency of drug application. There is an important incentive gap that hinders paediatric drug development resulting from a series of factors, such as small market size, a predominance of off-patent use, no incentives for generic drug manufacturers, and a greater complexity of drug development. The latter is due to varying capacities of drug absorption and metabolism during growth and maturation and the need for oral formulations in neonates and infants. High ethical barriers, combined with concerns of parents about drug safety, further complicate the conduct of clinical studies in children. While many off-patent antibiotics today are labelled for use in children, newer substances such as fluoroquinolones, azithromycin, linezolid, or daptomycin are not. This is of concern in the light of emerging multidrug-resistant pathogens.
Keywords: Antibiotic therapy, children, infants, neonates, off-label use, off-licensed, unlicensed, frequency of drug application, paediatric, adverse drug reaction
Current Drug Targets
Title:Antibiotic Use in Children - Off-Label Use
Volume: 13 Issue: 7
Author(s): Walter Zingg and Klara M. Posfay-Barbe
Affiliation:
Keywords: Antibiotic therapy, children, infants, neonates, off-label use, off-licensed, unlicensed, frequency of drug application, paediatric, adverse drug reaction
Abstract: Systemic antibiotics are the group of drugs most commonly used in children. Off-label antibiotic use in children is still common in the community and in hospitals, mostly because of young age, dosage, or frequency of drug application. There is an important incentive gap that hinders paediatric drug development resulting from a series of factors, such as small market size, a predominance of off-patent use, no incentives for generic drug manufacturers, and a greater complexity of drug development. The latter is due to varying capacities of drug absorption and metabolism during growth and maturation and the need for oral formulations in neonates and infants. High ethical barriers, combined with concerns of parents about drug safety, further complicate the conduct of clinical studies in children. While many off-patent antibiotics today are labelled for use in children, newer substances such as fluoroquinolones, azithromycin, linezolid, or daptomycin are not. This is of concern in the light of emerging multidrug-resistant pathogens.
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Cite this article as:
Zingg Walter and M. Posfay-Barbe Klara, Antibiotic Use in Children - Off-Label Use, Current Drug Targets 2012; 13 (7) . https://dx.doi.org/10.2174/138945012800675777
DOI https://dx.doi.org/10.2174/138945012800675777 |
Print ISSN 1389-4501 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-5592 |
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