Prescribing trends and spontaneous reporting patterns of adverse drug reactions of ADHD medications in children and adolescents in germany: A retrospective analysis (2013–2022)

Attention-deficit hyperactivity disorder (ADHD) is a common psychiatric disorder in children and adolescents. Prescribing restrictions driven by concerns about overdiagnosis led to declining ADHD prescriptions between 2010 and 2016. The prevalence of adverse drug reactions (ADRs) remains unclear, as many studies did not account for dropouts due to ADRs. The aim of our study was to analyse the more recent ADHD prescriptions, along with the number of spontaneous ADR reports received for ADHD drugs. Outpatient ADHD drug prescriptions for patients ≤ 17 years between 01/01/2013 and 31/12/2022 were provided by the Central Research Institute of Ambulatory Health Care. Applying these inclusion criteria 1,119 spontaneous ADR reports of ADHD drugs were extracted from the European ADR database, EudraVigilance. Reporting rates were calculated as the number of ADHD reports per 100,000 outpatient ADHD drug prescriptions. After declining trends, the number of ADHD prescriptions increased again from 2020 onwards. In contrast, prescriptions for pre-school children increased throughout the study period. An increasing number of spontaneous ADHD reports was observed after 2017, with a slight decline between 2021 and 2022. Overall, reporting rates for methylphenidate (6.7) were clearly lower than for atomoxetine (17.8), lisdexamfetamine (22.2), and guanfacine (19.7); however initial differences converged over the course of the study. The increasing number of ADHD drug prescriptions in recent years appears to contrast with the recommended restrictions on ADHD drug use and the current treatment guidelines. Our study supports the recommendation to use methylphenidate as first-line treatment in children and adolescents.