ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating seizure disorders.
The FDA announced Friday the approval of Sabril (vigabatrin) oral solution, made by Deerfield, Ill.-based Lundbeck. The drug is approved for treating infantile spasms in children ages 1 month to 2 years and is the first drug approved in the United States to treat the disorder.
The agency also approved Sabril tablets as a treatment for epileptic seizures in adults.
“Seizures can cause impaired nervous system function and reduced quality of life,” FDA Center for Drug Evaluation and Research Division of Neurology Products director Russell Katz said in a statement. “Infantile spasms in children this young are very serious, and this approval provides these patients and their parents a treatment option.”
Infantile spasms typically appear between the ages of 4 months and 8 months and can cause bending forward of the body, arching of the back and stiffening of the limbs. The spasms tend to occur after awakening or after feeding and can happen in clusters of up to 100.
The FDA said Sabril would carry a boxed warning, the agency’s strongest warning label, to alert healthcare professionals of the risk of permanent vision damage.