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.
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Acknowledgments, competing interests, funding
This report/article presents independent research commissioned by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (RP-PG-0606-1170).
JM is funded via this programme grant. MP is a NIHR Senior Investigator. MP also wishes to thank the DH (NHS Chair of Pharmacogenetics), MRC, Wellcome Trust and EU-FP7 programme for grant support. MP is a member of the Commission on Human Medicines and Chairs the Pharmacovigilance Expert Advisory Group.
The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, NIHR, the Department of Health or any of the other institutions that the authors represent.
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Mason, J., Pirmohamed, M. & Nunn, T. Off-label and unlicensed medicine use and adverse drug reactions in children: a narrative review of the literature. Eur J Clin Pharmacol 68, 21–28 (2012). https://doi.org/10.1007/s00228-011-1097-1
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DOI: https://doi.org/10.1007/s00228-011-1097-1