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US regulator licenses Trileptal for children

12 August, 2003

The US Food and Drug Administration has granted approval for Trileptal (oxcarbazepine) to be used as monotherapy in children with partial seizures four years of age and older, making it the first anti-epileptic drug to be approved as a monotherapy in children in the US since 1978.

The study showed that adverse side effects with Trileptal in children were similar to those in adults. The approval was granted on the basis of data from four trials involving more then 1,000 children.

Patricia Shafer, Chair of the Epilepsy Foundation of America's Professional Advisory Board, commented:

"As many parents of children with epilepsy know, managing complicated dosing regimens in children can be very difficult. The availability of Trileptal as a monotherapy should help simplify dosing for many patients and make compliance easier for many families."

Many children with epilepsy take multiple medications to control their seizures; however, treating seizure disorders with one medication is preferred as it usually means fewer side effects and improved compliance.