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.
Bourgeois
Blaise F D
BF
Department of Neurology, Children's Hospital, Harvard Medical School, Boston, MA, USA. blaise.bourgeois@childrens.harvard.edu
D'Souza
Joseph
J
D000293:Adolescent; D000927:Anticonvulsants / Q000009:adverse effects* / Q000627:therapeutic use*; D002220:Carbamazepine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002648:Child; D002986:Clinical Trials as Topic; D016208:Databases, Factual; D004311:Double-Blind Method; D004827:Epilepsy / Q000188:drug therapy*; D006801:Humans; D000078330:Oxcarbazepine; D016032:Randomized Controlled Trials as Topic
D000927:Anticonvulsants; D002220:Carbamazepine; D000078330:Oxcarbazepine