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[Specific features and problems in the pharmacotherapy of schizophrenic psychoses in children and adolescents]
1Klinik und Poliklinik für Kinder- und Jugendpsychiatrie/Psychotherapie, Universitätsklinikum Ulm. joerg.fegert@medizin.uni-ulm.de
Abstract:
The present article reviews the specific problems of the off-label use of atypical and typical neuroleptics in the treatment of adolescent patients with schizophrenia. There is a considerable gap in the empirical knowledge of treatment efficacy and long term safety in adult populations as compared to children and adolescents. This means that in most in-patients with early onset schizophrenia some sort of typical or atypical neuroleptic drug is currently used beyond license. From a legal point of view there is no protection for treated children or adolescents and their parents as the manufacturer of these pharmaceutical products does not assume liability for off-label use. Whether the doctor can be held liable in these cases, depends on the quality of the information he provides to his patients and the patients' consent. Legal changes such as the Food and Drug Administration Modernization Act (FDAMA) and Pediatric Rule in the USA have brought forward more research to the benefit of children and adolescents. In 2002 a trend has been noticed in both the European and the German Parliament to improve the general conditions for using drugs that are well-established in adult medicine for the treatment of children.