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Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice

Egberts, Karin M. ; Gerlach, Manfred ; Correll, Christoph U. ; Plener, Paul L. ; Malzahn, Uwe ; Heuschmann, Peter ; Unterecker, Stefan ; Scherf-Clavel, Maike ; Rock, Hans ; Antony, Gisela ; Briegel, Wolfgang ; Fleischhaker, Christian ; Häge, Alexander ; Hellenschmidt, Tobias ; Imgart, Harmut ; Kaess, Michael ; Karwautz, Andreas ; Kölch, Michael ; Reitzle, Karl ; Renner, Tobias ; Reuter-Dang, Su-Yin ; Rexroth, Christian ; Schulte-Körne, Gerd ; Theisen, Frank M. ; Walitza, Susanne ; Wewetzer, Christoph ; Fekete, Stefanie ; Taurines, Regina ; Romanos, Marcel



Abstract

Introduction Despite the growing evidence base for psychotropic drug treatment in pediatric patients, knowledge about the benefit-risk ratio in clinical practice remains limited. The 'Therapeutic Drug Monitoring (TDM)-VIGIL' study aimed to evaluate serious adverse drug reactions (ADRs) in children and adolescents treated with antidepressants and/or antipsychotics in approved ('on-label'), and ...

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