FDA News: Sabril (Vigabatrin) Approved for Use in Focal Epilepsy for Children Over 2 Years Old

The U.S. Food and Drug Administration (FDA) has approved the use of Sabril^® (vigabatrin) for use in people with refractory or drug-resistant focal epilepsy in people 2 years of age and older. It is intended to be used in addition to other seizures medicines.

Previously vigabatrin was used in people with focal impaired awareness seizures, previously called complex partial seizures, only if they were 10 years or over. 

It is also approved for use with infants from 1 month to 2 years of age with infantile spasms (IS). 

Since many infants with IS also develop focal epilepsy, vigabatrin was not approved for use in these children if they were between 2 and 10 years old. For many children, this left a major gap in their care and seizure control.

The brand name for vigabatrin, Sabril, is made by Lundbeck. Generic formulations are also available.