FDA OKs Sabril to Treat Infantile Spasms
Drug Also Approved to Help Treat Seizures in Adults; Will Come With 'Black Box' Warning About Vision Risk
Aug. 21, 2009 -- The FDA announced that it has approved the drug Sabril to treat infantile spasms in children ages 1 month to 2 years and to help treat complex partial seizures in adults.
Sabril Oral Solution is the first drug approved in the U.S. to treat infantile spasms, a severe type of seizure that usually appears in the first year of life, typically when babies are 4-8 months old. The disorder can be debilitating because of the frequency of difficult-to-control daily seizures.
Infantile spasms consist primarily of a sudden bending forward of the body with stiffening of the arms and legs; some children arch their backs as they extend their arms and legs. Spasms tend to occur upon awakening or after feeding, and often occur in clusters of up to 100 spasms. Infants may have dozens of clusters and several hundred spasms per day. Many underlying disorders, such as birth injury, metabolic disorders, and genetic disorders can give rise to spasms, making it important to identify the underlying cause. In some children, no cause can be found.
Sabril tablets are also approved for adult use in combination with other medications to treat complex partial seizures that haven't responded adequately to previous drug therapies. Sabril is not indicated as a first-line treatment for those seizures, notes Lundbeck, the drug company that makes Sabril.
Sabril's active ingredient is called vigabatrin. The drug belongs to an antiepileptic class of drugs.
Sabril is already available in other countries, and vigabatrin has been studied as a treatment for drug addiction and weight loss. But until now, it had not been approved in the U.S.
Black Box Warning About Vision Risk
"Damage to vision is an important safety concern with the use of Sabril," the FDA states in a news release.
Sabril will have a "black box" warning, the FDA's sternest warning, about the risk of a progressive loss of peripheral vision with potential decrease in visual acuity.
The FDA states that the risk of vision damage may increase based on the dosage and duration of use, but even the lowest doses of Sabril can cause vision damage.
Because of the risk of permanent vision damage, the drug will be available only through a restricted distribution program.
In a news release, Lundbeck states that it plans to launch Sabril in the U.S. during the third quarter of 2009, with an extensive risk evaluation and mitigation strategy required by the FDA and created in collaboration with the FDA.