Off-label use of drugs in children

Kathleen A. Neville, Daniel A C Frattarelli, Jeffrey L. Galinkin, Thomas P. Green, Timothy D. Johnson, Ian M. Paul, John N. Van Den Anker

Research output: Contribution to journalShort surveypeer-review

277 Scopus citations


The passage of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act has collectively resulted in an improvement in rational prescribing for children, including more than 500 labeling changes. However, off-label drug use remains an important public health issue for infants, children, and adolescents, because an over-whelming number of drugs still have no information in the labeling for use in pediatrics. The purpose of off-label use is to benefit the individual patient. Practitioners use their professional judgment to determine these uses. As such, the term "off-label" does not imply an improper, illegal, contraindicated, or investigational use. Therapeutic decision-making must always rely on the best available evidence and the importance of the benefit for the individual patient.

Original languageEnglish (US)
Pages (from-to)563-567
Number of pages5
Issue number3
StatePublished - 2014


  • Adolescents
  • Children
  • Infants
  • Off-label drug use
  • Pediatrics
  • Pharmaceuticals
  • Prescribing

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health


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