title: Off-label and unlicensed medicine use and adverse drug reactions in children: a narrative review of the literature.
abstract: The use of unlicensed and off-label medicines in children is common because trials in children have not usually been performed during the drug development process. Consequently, the information available to paediatricians may not always be as detailed or as robust as that available when prescribing a medicine that is licensed for an approved indication. This has led to concerns that children may be receiving drugs at dosages that either lack efficacy or present safety problems. The latter in particular has received a great deal of attention. In this narrative review, we have evaluated the use of off-label and unlicensed medicines in children and whether and how frequently this predisposes to adverse drug reactions.
authors.affiliation: Alder Hey Children's NHS Foundation Trust, Eaton Road, Liverpool, L12 2AP, UK. jennifer.mason@alderhey.nhs.uk
authors.forename: Jennifer
authors.initials: J
authors.lastname: Mason
authors.forename: Munir
authors.initials: M
authors.lastname: Pirmohamed
authors.forename: Tony
authors.initials: T
authors.lastname: Nunn
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D002648:Child; D003875:Drug Eruptions / Q000453:epidemiology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000453:epidemiology*; D015507:Drugs, Investigational / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D007880:Legislation, Drug; D056687:Off-Label Use; D010818:Practice Patterns, Physicians'
chemical_list: D015507:Drugs, Investigational