Children and adolescents are regularly excluded from clinical registration trials, leading to a limited range of indications for these drugs. Therefore, many of these drugs are frequently used “off label” in the treatment of children and adolescents. This also applies to psychotropic drugs, including antipsychotics and antidepressants. While adverse events (AEs) like muscle cramps, cardiovascular symptoms, and increased rates of suicidal ideation are well described for the adult population, their frequencies among minors remain understudied.
Multi-sectoral secondary data such as claims data from statutory health insurances provide the option of depicting the real practice of off-label-prescriptions and associated AEs of psychotropic drugs in children and adolescents – longitudinally and representative for larger populations. As an example, in a large study sponsored by the Federal Institute for Drugs and Medical Devices, BfArM, we could show that from 2004-2011 antipsychotics and antidepressants were prescribed to approximately 1-2 out of 1,000 minors. For both drug classes, only low rates of AEs were detected. Currently, further analyses for specific subgroups, such as users of stimulants, are conducted (see also research topic “Attention-deficit/ hyperactivity disorder”).
- Schröder, C., Dörks, M., Kollhorst, B., Blenk, T., Dittmann, R., Garbe, E. & Riedel, O. (in press). Outpatient antipsychotic drug use in children and adolescents in Germany between 2004 and 2011. European Child & Adolescent Psychiatry. doi: 10.1007/s00787-016-0905-7.
- Schröder, C., Dörks, M., Kollhorst, B., Blenk, T., Dittmann, R., Garbe, E. & Riedel, O. (in press). Outpatient antidepressant drug use in children and adolescents in Germany between 2004 and 2011. Pharmacoepidemiology and Drug Safety.