Foundation Officials Welcome FDA Approval of New Monotherapy Treatment for Children

Posted: August 7, 2003

Representatives of the Epilepsy Foundation said they welcomed the Food and Drug Administration’s action Aug. 7, in approving oxcarbazapine (Trileptal) as monotherapy in the treatment of partial seizures in children age 4 and above. The announcement gives families and their physicians another potential alternative to the multiple anti-epileptic medications that many children take each day to control their seizures.

Gregory L. Barkley, M.D., medical director of the Henry Ford Comprehensive Epilepsy Program in Detroit and chair-elect of the Foundation’s professional advisory board, said, “It’s always encouraging when new options are approved for the treatment of children with epilepsy. Epilepsy specialists have prescribed Trileptal in monotherapy in adults and children for some time but most other physicians have not. Unfortunately, many physicians are reluctant to use an anti-convulsant in monotherapy without a specific monotherapy indication from the FDA even though the FDA specifically allows physicians to use medications beyond the narrow boundaries of the approved labeling. Thus the pediatric monotherapy indication should give general neurologists and primary care physicians greater confidence in treating pediatric patients with this medication.”

Indications for which Trileptal has previous FDA approval are as monotherapy in adults and as adjunctive therapy in adults and children.

According to Eric Hargis, Foundation president and CEO, “Children on multiple medications may take a dozen or more pills a day. In addition to the complicated treatment schedule this imposes on the family, quality of life for the child may be significantly reduced by the cumulative effect of medications,” he said. “Taking a single medication can make treatment easier and life more pleasant for these children.”

Of the 2.3 million people with epilepsy in the United States, 316,000 (14 percent) are age 14 and under, and 45,500 new cases of seizures and epilepsy occur in this age group each year.