August 24, 2009 — 美國食品藥物管理局(FDA)已經核准Vigabatrin口服溶液(Sabril,Lundbeck有限公司)用於治療嬰兒筋攣,以及1個月至2歲兒童的癲癇發作。
  FDA藥物評估與研究中心神經產品部門主任Russell Katz醫師在一篇FDA新聞稿中表示,癲癇發作會損害神經功能,並且降低生活品質。

FDA Approves Vigabatrin Oral Solution for Treating Infantile Spasms

By Brande Nicole Martin
Medscape Medical News

August 24, 2009 — The US Food and Drug Administration (FDA) has approved vigabatrin oral solution (Sabril, Lundbeck Inc) to treat infantile spasms and epileptic seizures in children aged 1 month to 2 years.

This is the first drug approved in the United States to treat this disorder.

Infantile spasms are a severe type of seizure that occurs in children during the first year of life, usually between ages 4 and 8 months. During the spasms, children will suddenly bend forward and stiffen their arms and legs. Some children will arch their backs as they extend their arms and legs.

The spasms occur in clusters of up to 100 spasms, and a child may have dozens of clusters and several hundred spasms throughout the day. They usually occur on awakening or after a feeding.

Underlying disorders, such as birth injury, metabolic disorders, and genetic disorders, may trigger spasms. These underlying disorders should be identified, but no underlying cause is found in some children.

The frequency and difficulty in controlling the seizures make the disorder debilitating for a child.

"Seizures can cause impaired nervous system function and reduced quality of life," said Russell Katz, MD, director of the Division of Neurology Products at the FDA's Center for Drug Evaluation and Research, in an FDA news release.

Vision damage is an important adverse event with use of vigabatrin. The drug will have a boxed warning to notify healthcare professionals of the risk for progressive loss of peripheral vision with a potential decrease in visual acuity. The drug dosage and duration may increase vision damage, but even the lowest doses of the drug may cause vision damage.

Vigabatrin will be available only through a restricted distribution program because of the risk for permanent vision damage. Patients using the drug will be required to have periodic vision tests.

Vigabatrin tablets were also approved in combination with other drugs to treat complex partial seizures refractory to previous drug treatments in adults.

The drug previously was designated as an orphan drug to treat infantile spasms.