Prescribing medications in pediatrics: concerns regarding FDA approval and pharmacokinetics

Pediatr Nurs. Jan-Feb 2007;33(1):64-70.


Prescribing medications "off-label" is a common practice in pediatric health care since many medications lack U.S. Food and Drug Administration (FDA) approval for pediatric drug labeling due to insufficient drug testing in children. This clinical paper reviews the FDA laws regarding approval of medications in children and the pharmacokinetic differences in absorption, distribution, metabolism and excretion between children and adults. Two commonly used pharmacology resources were reviewed to determine their identification of FDA approved indications in children and dosing recommendations by age or weight in children. Adhering to the "community's standard of care" is a common guideline for prescribing "off-label" in pediatrics, but must be used in combination with multiple respected pediatric resources and with full knowledge of pharmacokinetics in children, particularly in young children.

Publication types

  • Review

MeSH terms

  • Age Factors
  • Child
  • Drug Approval / legislation & jurisprudence*
  • Drug Labeling / legislation & jurisprudence
  • Drug Prescriptions / standards*
  • Drug Utilization Review
  • Humans
  • Intestinal Absorption / physiology
  • Metabolic Clearance Rate / physiology
  • Patient Selection
  • Pediatrics / organization & administration*
  • Pharmacokinetics
  • Practice Guidelines as Topic
  • Practice Patterns, Physicians' / organization & administration*
  • Primary Health Care / organization & administration
  • Tissue Distribution / physiology
  • United States
  • United States Food and Drug Administration / legislation & jurisprudence*