FDA核准Vigabatrin口服溶液治療嬰兒筋攣


  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。
  
  這是在美國第一個獲得核准治療這個疾病的藥物。
  
  嬰兒筋攣是一種發生在出生後一年間的嚴重癲癇,通常在第4到第8個月之間發生。在筋攣時,兒童會突然捲曲向前,且手臂與腳僵硬。部分兒童在伸展手臂與腿時會弓起背部。
  
  這些筋攣經常密集發生,可能高達100次,且一位病童可能發生多達10幾次的密集發作,每天甚至發生數百次筋攣。這些筋攣通常發生在醒來時,或是餵食後。
  
  相關的疾病,例如出生時的傷害、代謝異常、與基因異常都可能誘發筋攣。應該要找出這些相關異常,但是部分病童仍然無法找出病因。
  
  這些癲癇的發作頻率以及難以控制,會讓一位病童變得非常衰弱。
  
  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。
  
  視覺損傷是另一個使用Vigabatrin的重要不良反應。該藥物的仿單中將會有一個黑框警訊提醒健康照護專家,使用這個藥物可能帶來的漸進性周邊視覺缺損、與視力減退的可能性。藥物的劑量與使用時間長短可能增加視覺損害的機率,但是即使使用最低劑量,仍然可能造成視覺損傷。
  
  因為永久的視覺損傷,Vigabatrin將只能在受限制的分配計畫下取得。使用這個藥物的病患將被要求進行定期視力檢查。
  
  Vigabatrin也被核准合併其他治療複雜性局部癲癇發作藥物,使用於對治療反應不佳的成人。
  
  該藥物過去以孤兒藥的方式用於治療嬰兒筋攣。
  

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.

    



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