Abstract |
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.
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Authors | Blaise F D Bourgeois, Joseph D'Souza |
Journal | Epilepsy & behavior : E&B
(Epilepsy Behav)
Vol. 7
Issue 3
Pg. 375-82
(Nov 2005)
ISSN: 1525-5050 [Print] United States |
PMID | 16176888
(Publication Type: Journal Article, Review)
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Chemical References |
- Anticonvulsants
- Carbamazepine
- Oxcarbazepine
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Topics |
- Adolescent
- Anticonvulsants
(adverse effects, therapeutic use)
- Carbamazepine
(adverse effects, analogs & derivatives, therapeutic use)
- Child
- Clinical Trials as Topic
- Databases, Factual
- Double-Blind Method
- Epilepsy
(drug therapy)
- Humans
- Oxcarbazepine
- Randomized Controlled Trials as Topic
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