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- Roberto Bernardini, Gaia Toschi Vespasiani, and Arianna Giannetti.
- Paediatrics and Neonatology Unit, San Giuseppe Hospital, 50053 Empoli, Italy.
- Medicina (Kaunas). 2022 Apr 29; 58 (5).
AbstractIn recent years, off-label and unlicensed drug use has extensively developed in the paediatric population. For a long time, clinical trials in the paediatric population were considered complicated to perform because of ethical problems, causing frequent off-label use. Off-label drug use remains an important public health issue, especially for children with rare conditions or with diseases not responsive to conventional treatments. The present paper is a narrative review of the literature of off-label drug use in children. The aim of our study is to summarize the main works dealing with the off-label use of biological drugs in paediatrics. Further studies analyzing their efficacy, safety, and cost-benefit ratios are needed to extend the use of biological therapies to the paediatric population.
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