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Updated: May 23, 2026
11:17
Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
Published on: August 30, 2018
Antibiotic use in children - off-label use
Walter Zingg1, Klara M Posfay-Barbe
1Infection Control Program, University of Geneva Hospitals, 4 Rue Gabrielle Perret-Gentil, 1211 Geneva 14, Switzerland. walter.zingg@hcuge.ch
Current Drug Targets
|April 20, 2012
Summary
Off-label antibiotic use in children is common due to development challenges and a lack of incentives for new drug formulations. Addressing these issues is crucial for combating rising multidrug-resistant pathogens in pediatric populations.
Area of Science:
- Pediatric pharmacology
- Infectious disease management
- Drug development economics
Background:
- Systemic antibiotics are frequently prescribed for pediatric patients.
- Off-label antibiotic prescribing remains prevalent in both community and hospital settings for children.
- Factors contributing to off-label use include patient age, incorrect dosage, and administration frequency.
Purpose of the Study:
- To highlight the significant incentive gap hindering pediatric drug development, particularly for antibiotics.
- To identify key challenges in developing and approving new antibiotic agents for pediatric use.
- To underscore the implications of limited approved antibiotic options for children in the face of antimicrobial resistance.
Main Methods:
- Review of existing literature on pediatric antibiotic use and drug development.
- Analysis of economic and regulatory factors impacting pharmaceutical research for pediatric populations.
- Examination of the complexities in pediatric drug formulation and clinical trial conduct.
Main Results:
- A substantial incentive gap exists for pediatric antibiotic development, driven by small market size and a high prevalence of off-patent drug use.
- Developing new antibiotics for children is complicated by physiological variations, the need for specific formulations (e.g., oral for neonates), and ethical considerations.
- While older antibiotics are often labeled for pediatric use, newer agents like fluoroquinolones and azithromycin lack such approvals.
Conclusions:
- The lack of approved indications for newer antibiotics in children poses a significant risk, especially with the rise of multidrug-resistant pathogens.
- Addressing the economic and scientific barriers is essential to ensure appropriate and effective antibiotic treatment options for pediatric infections.
- Further research and policy interventions are needed to incentivize the development and approval of novel antibiotics for the pediatric population.
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