Vigabatrin (Sabril) Approved by FDA

Vigabatrin (Sabril®) was approved on 8/21/09 by the US FDA for treatment of infantile spasms in children, and uncontrolled complex partial seizures in adults, according to Lundbeck, Inc., a pharmaceutical company.

Vigabatrin is a "designer drug,"” made to block the metabolism and clearance from the body of GABA, the brain’s most important inhibitory chemical. Administration of vigabatrin leads to a buildup of GABA in brain synapses, and this partially counteracts the excitation occurring during seizures. Vigabatrin can be a particularly useful treatment for infantile spasms in children ages one month to two years of age. These seizures are difficult to treat, especially since a formerly used treatment, ACTH, is sometimes difficult to obtain. Although vigabatrin is available in dozens of countries around the world, it has not previously been available in the US, because the drug can be toxic to the retina of the eye and cause sometimes permanent loss of peripheral vision. The FDA now has approved use of vigabatrin in the US for situations in which the potential benefit against seizures outweighs the risk of visual loss. Monitoring of vision will be needed for people taking this drug, since up to 30% of people taking Sabril may have some visual loss. Sabril will be available in 500 mg tablets and also 500 mg powder packets to make oral solutions. Availability of vigabatrin in pharmacies and formularies can be expected sometime later this year. When available, more information about the drug will be obtainable in the seizure medicines section of epilepsy.com.