Off-label use in child and adolescent psychiatry. An ongoing ethical, medical and legal problem

Off-label use is an ongoing problem in child and adolescent psychiatry. Except methylphenidate and atomoxetine for attention-deficit/hyperactivity disorder (ADHD), most substances used to treat children and adolescents with psychiatric disorders are prescribed off-label. In additional to aspects of drug safety and efficacy the widespread off-label use raises issues of liability in the case of adverse events. In Germany off-label use also poses problems of reimbursement by the health insurance. In the future we expect, driven by written request of the FDA, numerous new indications for novel antipsychotics in the USA for the treatment of so-called childhood bipolar disorders. Given another diagnostic framework in context in Europe, these so-called bipolar disorders in children are very rarely diagnosed. Anyhow, antipsychotics are widely used in the USA and in Europe to treat iimpulsivity or aggressiveness in children and adolescents. There is still a lack of European labelling of novel antipsychotics for the treatment of schizophrenia. In clinical practice given the risk of liability and other forensic issues in the treatment of schizophrenic patients, this is still one of the major hindrances in the treatment of young schizophrenic patients in Europe. Whereass these drugs may urgently be needed for treatment of psychotic disorders and of impulsivity or aggressiveness, the indication of bipolar as used in the USA leads to a misconception and does not increase availability of licensed modern antipsychotics for minors.