Safety and tolerability of zonisamide in paediatric patients with epilepsy

Abstract Background Zonisamide has recently been approved in Europe for the adjunctive treatment of partial seizures (with or without secondary generalisation) in adolescents and children aged ≥6 years. Aim To further assess the safety of adjunctive zonisamide in paediatric epilepsy patients. Methods A pooled analysis of data from 17 studies (including four randomised, double-blind trials) was conducted. The safety population comprised patients aged ≤16 years receiving at least one dose of study drug. Assessments included treatment-emergent adverse events (TEAEs), clinical laboratory parameters, vital signs and electrocardiography. Results The analysis included 398 patients treated with zonisamide (