TUESDAY, Jan. 21, 2003 (HealthDayNews) -- A drug to treat children with the most common form of epilepsy has been approved by the U.S. Food and Drug Administration, says the drug's maker, GlaxoSmithKline.
Lamictal (lamotrigine) had been approved for treatment of so-called "partial seizures" in adults, but the new approval allows it to be marketed for the same use in children ages 2 years and older. Lamictal is recommended for children who are still having seizures, despite treatment with other epilepsy drugs.
Affecting 70 percent of all people with epilepsy, partial seizures are the most common form of the disease, involving abnormal electrical activity in a particular part of the brain. Symptoms may include a dazed state, lip smacking, or jerking movements.
According to Epilepsy Foundation statistics cited by the drugmaker, epilepsy affects some 2.3 million Americans, including 300,000 children under age 14.
FDA approval for Lamictal was granted after an 18-week clinical trial involving 199 patients ages 2 to 16. Those who received Lamictal in addition to their other medications experienced 36 percent fewer seizures, compared with a 7 percent reduction among those who received a non-medicinal pill. Common side effects included a serious rash, dizziness, tremor, and nausea.
Here is the GlaxoSmithKline press release announcing the approval. For more information about epilepsy, visit the Epilepsy Foundation.
