[Off-label use of drugs in pediatric emergencies: limitations and grey areas of drug approval].
In the medical treatment of children drugs are frequently used outside the boundaries of the approved licensing and use under the terms of off-label use is possible. However, this requires critical reasoning and experience with the drug involved. With help of a traffic light colored spreadsheet this article illustrates the limitations, problems and possibilities of pharmacotherapy in pediatric emergencies or pediatric anesthesia. Of the 45 emergency drugs listed in this article most can be used in childhood, at least under specific conditions. Licensing restrictions occur especially in the newborn period and infancy resulting in frequent off-label use. Severe pitfalls, such as the propofol infusion syndrome after long-term sedation with propofol under the age of 16 years, emphasize the need for serious reflection on the substances involved. Decisions regarding pharmaceutical therapy should be based on the current standard of medical knowledge. When official recommendations from pharmaceutical companies are missing, treatment decisions for off-label use can be based on guidelines, study and literature databases or recommendations in medical journals.
Klinik für Anästhesie und operative Intensivmedizin, Bereich Kinderanästhesie, St. Franziskus-Hospital Münster, Hohenzollernring 72, 48145 Münster, Deutschland. christian.erker@sfh-muenster.de
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D002648:Child; D002675:Child, Preschool; D016292:Procedural Sedation; D017277:Drug Approval; D004632:Emergency Medical Services / Q000331:legislation & jurisprudence / Q000379:methods*; D017408:Guidelines as Topic; D006801:Humans; D007231:Infant, Newborn; D056687:Off-Label Use / Q000331:legislation & jurisprudence; D010372:Pediatrics / Q000331:legislation & jurisprudence / Q000379:methods*; D010599:Pharmacokinetics