The use of unlicensed and off-label medicines in the neonate

Semin Fetal Neonatal Med. 2005 Apr;10(2):115-22. doi: 10.1016/j.siny.2004.11.003. Epub 2005 Jan 25.


The use of unlicensed and off-label medicines in neonates in intensive care is common and widespread. Up to 93% of babies receive at least one unlicensed or off-label medicine during their stay in intensive care. Such practice is an essential part of their care and should be done based on the best evidence available. However, problems arise - on an every-day basis - because of the lack of appropriate information and licensed medicine formulations for neonates. These problems include the selection of appropriate medicine and dose, administration and the increased risk of medication errors. Initiatives to improve the situation are underway in the US and are proposed in Europe. However, more urgent action is required to stop these babies continuing to be deprived of their basic human rights to safe, effective and high-quality therapy.

Publication types

  • Review

MeSH terms

  • Contraindications
  • Critical Care
  • Dosage Forms
  • Drug Administration Routes
  • Drug Compounding
  • Drug Labeling / legislation & jurisprudence*
  • Europe
  • Humans
  • Infant, Newborn
  • Legislation, Drug*
  • Pharmaceutical Preparations / administration & dosage*
  • Primary Health Care
  • United States


  • Dosage Forms
  • Pharmaceutical Preparations