Long-term safety and tolerability of oxcarbazepine in children: a review of clinical experience.

Relatively few well-designed studies have demonstrated the long-term safety and tolerability of newer antiepileptic drugs (AEDs) in a large group of children. Extensive clinical data from the worldwide Clinical Development Program (CDP) and a compassionate use program on the safety and tolerability of oxcarbazepine in children are presented. Oxcarbazepine is a newer AED that is indicated for use as monotherapy and adjunctive therapy in children (United States 4 years of age, Europe 6 years of age) with partial epilepsy. The most common adverse events (10%) in the CDP were headache (32.5%), somnolence (31.5%), vomiting (27.6%), and dizziness (23.1%), whereas in the compassionate use program (clinical practice situation), the most common adverse events (1%) reported were rash (2.7%), fatigue (1.6%), nausea (1.2%), and somnolence (1.2%). These data indicate that oxcarbazepine has a good long-term safety and tolerability profile, whether given as monotherapy or adjunctive therapy, in children with partial seizures.