Healthy Skepticism Library item: 10131
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Novak E, Allen PJ.
Prescribing medications in pediatrics: concerns regarding FDA approval and pharmacokinetics.
Pediatr Nurs 2007 Jan-Feb; 33:(1):64-70
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17411005&query_hl=4&itool=pubmed_DocSum
Abstract:
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.
Keywords:
Publication Types:
Review
MeSH Terms:
Age Factors
Child
Drug Approval/legislation & jurisprudence*
Drug Labeling/legislation & jurisprudence
Drug Utilization Review
Humans
Intestinal Absorption/physiology
Metabolic Clearance Rate/physiology
Patient Selection
Pediatrics/organization & administration*
Pharmacokinetics
Physician's Practice Patterns/organization & administration*
Practice Guidelines
Prescriptions, Drug/standards*
Primary Health Care/organization & administration
Tissue Distribution/physiology
United States
United States Food and Drug Administration/legislation & jurisprudence*
