Unlicensed and off-label drug use in children: implications for safety

Expert Opin Drug Saf. 2004 Mar;3(2):81-3. doi: 10.1517/eods.


Throughout the world, many drugs prescribed for children are used in an off-label or unlicensed manner. The incidence of unlicensed and off-label drug prescriptions appears to be greatest in critically ill neonates and children and lowest in the general population. The risk associated with unlicensed and off-label drug use appears to be greater than for prescribing in accordance with the product licence. Health professionals, however, usually have no alternative but to use unlicensed and off-label medicines. More clinical trials for medicines in children are required to provide the evidence base for safe and effective drug prescribing.

Publication types

  • Editorial

MeSH terms

  • Child
  • Drug Approval / legislation & jurisprudence*
  • Drug Labeling* / classification
  • Drug Labeling* / legislation & jurisprudence
  • Drug Therapy / statistics & numerical data
  • Drug Utilization
  • Drug-Related Side Effects and Adverse Reactions*
  • Humans
  • Practice Patterns, Physicians'*