Extent and risks of antidepressant off‐label use in children and adolescents in Germany between 2004 and 2011

Abstract Purpose So far, only little is known about antidepressant off‐label use in pediatric patients. This is the first study examining the prevalence and the risks of off‐label antidepressant prescriptions in minors over time in Germany and analyzing patterns regarding age, sex, drug class, and type of off‐label use. Methods We used claims data of about two million individuals (<18 y) to calculate the share of off‐label antidepressant prescriptions for the years 2004 to 2011, stratified by age, sex, and drug class. Off‐label prescriptions were analyzed regarding underlying diagnoses, the prescribing doctor's specialty, and the type of off‐label use. Incidence rates of adverse events were calculated for off‐ and on‐label use, and the risk of suicidal events associated with off‐ or on‐label use was examined in a nested case‐control study. Results The prevalence of off‐label prescriptions decreased from 58.0% to 40.9%. Selective serotonin reuptake inhibitors were more frequently prescribed off‐label than tricyclic antidepressants (37.7% vs 17.5% in 2011). The most common type of off‐label use was off‐label use by age, followed by off‐label use by indication, and off‐label use by contraindication. Adverse events were rare with no significant differences between on‐ and off‐label use. Conclusions Although off‐label antidepressant use in minors decreased over time, it is still common. However, this rather indicates a lack of approved drugs for the treatment of depression in this population than inappropriate medical treatment. This is supported by the fact that off‐label use was not associated with a higher risk of adverse events than on‐label use.