LAUSR

Introduction Weight gain and obesity are common adverse effects of antipsychotics (APs). We aimed to assess AP-induced weight gain in pediatrics compared to adults. Methods In a case-non case study using the WHO global database of individual case safety reports (ICSRs), VigiBase®, we evaluated the existence of disproportionality in weight gain reporting under antipsychotic treatment in children and adolescents compared to adults. Disproportionality of weight gain reporting was evaluated using the reporting odds ratio (ROR) with corresponding 95% confidence intervals (95%CI). Analysis was adjusted for sex, reporting country, year of notification, reporter qualification and concomitant use of antidepressants (ADs) and lithium. Results A total of 282,224 ICSRs reported with an AP were retrieved: 6,446 (2.3%) in children, 14,112 (5%) in adolescents and 261,666 (92.7%) in adults. In children, 1,544 (24%) of ICSRs reported weight gain, 1,831 (13%) in adolescents and 13,506 (5.6%) in adults. Most weight gain cases concerned male patients (55%) and were reported by health professionals (47%) in North America (54%) and Europe (27%). Concomitant use of ADs and lithium was reported in 36% and 3.5% of weight gain cases overall. Disproportionality of weight gain reporting associated with APs was found in adolescents (adjusted ROR: 2.3 [95%CI 2.1–2.4]) and in children (aROR: 3.6 [95%CI 3.3–3.8]) compared to adults. Use of risperidone was associated with the highest increase in weight gain reporting in children (aROR 4.9, 95%CI 3.9–6.1) and adolescents (aROR 3.6, 95%CI 3.1–4.1). Conclusions Children and adolescents are at higher risk of reporting weight gain under APs than adults.