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FDA approves medication to treat infantile spasms
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Vigabatrin oral formulation has received FDA approval for treating infantile spasms, a severe type of seizure that typically occurs between the ages of 4 months and 8 months.
This is the first drug approved to treat this condition in children.
“Seizures can cause impaired nervous system function and reduced quality of life,” Russell Katz, MD, director of the Division of Neurology Products at the FDA’s Center for Drug Evaluation and Research said in a press release. “Infantile spasms in children this young are very serious and this approval provides these patients and their parents a treatment option.”
Vigabatrin (Sabril, Lundbeck Inc.) tablets have also been approved for adult combination therapy to treat complex partial seizures that have not adequately responded to previous drugs.
The medication will have a boxed warning to alert health care providers about safety concerns regarding permanent vision damage, including progressive loss of peripheral vision with a potential decrease in visual acuity. Vigabatrin will be available only through a restricted distribution program and periodic vision testing will be required for patients taking the medication.