Basics pp 19-27 | Cite as

Off-Label Drugs in Pediatric Perioperative Medicine

  • Marinella Astuto
  • Manuela Antoci
  • Antonino Gullo
Part of the Anaesthesia, Intensive Care and Pain in Neonates and Children book series (AICPNC)


The drug licensing system was introduced with the aim of ensuring that medicines are marketed only after having been examined for safety, efficacy and quality. So, before a drug is allowed on the market, a favorable balance between beneficial and harmful effects has to be demonstrated. Often this has been established only in adults and once a drug is approved, it may be prescribed by a physician for any population or disease state desired. Many drugs pass through the licensing process without being evaluated in children. The product license often contains statements such as “not recommended for use in children” or “no evidence for use in children.” This usually reflects an absence of data in children rather than a specific reason for the drug not to be used.


Pediatric Intensive Care Unit Paediatric Ward Product License License Drug Pediatric Clinical Trial 


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Copyright information

© Springer-Verlag Italia 2009

Authors and Affiliations

  • Marinella Astuto
    • 1
  • Manuela Antoci
    • 2
  • Antonino Gullo
    • 1
  1. 1.Department of Anesthesia and Intensive Care, Pediatric Anesthesia and Intensive Care SectionCatania University HospitalCataniaItaly
  2. 2.Department of Anesthesia and Intensive Care, Postgraduate School of Anesthesia and Intensive CareCatania University HospitalCataniaItaly

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