Sabril Approved for Infantile Spasms

In children ages 1 month to 2 years

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FRIDAY, Aug. 21, 2009 (HealthDay News) -- Sabril (vigabatrin) Oral Solution has been approved by the U.S. Food and Drug Administration to treat infantile spasms in children aged 1 month to 2 years, the agency said Friday in a news release.

Infantile spasms is characterized by severe seizures that typically start between ages 4 months and 8 months. Affected children tend to suddenly bend their bodies forward while their arms and legs stiffen. This behavior often occurs upon awakening or after the child eats, and may come in groups of up 100 spasms, the FDA said.

Underlying conditions that may give rise to the disorder include birth injury, metabolic problems and genetic abnormalities.

Sabril's label will include the agency's most severe "black box" warning that the drug's use could lead to progressive loss of peripheral vision, which could be dependent on dosage and duration of use, the FDA said. The drug will only be available via a restricted distribution program, and users will be required to undergo periodic vision testing.

Sabril was approved as an orphan drug, meaning the condition it treats affects fewer than 200,000 people in the United States, the agency said.

The drug is produced by Deerfield, Ill.-based Lundbeck Inc.

More information

The FDA has more about this approval.


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