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FDA approves clobazam (Onfi) for epilepsy

Some types of epilepsy cause seizures so brief and so subtle that they aren't recognized for what they are. But these so-called "petit mal" seizures can hamper a child's ability to pay attention, says Dr. Hallowell. iStockPhoto

(CBS) The drug clobazam (Onfi) has been approved by the FDA for the treatment of a rare but severe form of epilepsy in adults and in children age two or older.

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"Lennox-Gastaut syndrome is a severe form of epilepsy that causes debilitating seizures," Dr. Russell Katz, director of the division of neurology products in the agency's Center for Drug Evaluation and Research, said in a written statement. "This is a difficult condition to treat, and it will be helpful to have an additional treatment option."

Onfi is manufactured for Lundbeck Inc. by Catalent Pharma Solutions of Winchester, Ky. It's been on the market for years in other countries for treating anxiety and convulsions, Medpage Today reported.

Lennox-Gastaut, which typically begins before age four, can be caused by a number of conditions, including severe head injuries, central nervous system infections, and inherited degenerative or metabolic conditions. It causes a variety of seizure types, including so-called tonic seizures (marked by stiffening of the body, upward movement of the eyes, pupil dilation, and altered breathing patterns) atonic (brief loss of muscle tone and consciousness, causing abrupt falls), atypical absence (staring spells), and myoclonic (sudden muscle jerks).

In addition, the symdrome is associated with impaired mental function, behavior problems, and developmental delays.

Clobazam was shown to be effective against seizures in two large studies.

In addition to dependency, the drug can cause a variety of side effects including sleepiness, fever, drooling, constipation, cough, urinary tract infection, sleeplessness (insomnia), and aggression. And like other seizure drugs, clobazam may increase the risk of suicidal thoughts and actions in a small number of people who take it.

According to Medpage Today, the drug should be in U.S. pharmacies in early 2012.

The National Institute of Neurological Disorders and Stroke has more on Lennox-Gastaut syndrome.

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