MONDAY, Oct. 24 (HealthDay News) -- Onfi (clobazam) tablets have been approved by the U.S. Food and Drug Administration as an add-on treatment for severe seizures associated with Lennox-Gastaut syndrome in people 2 years and older, the agency said Monday in a news release.
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Lennox-Gastaut typically begins before age 4, and may be caused by factors including brain malformation, severe head injury, central nervous system infection and a number of genetic conditions, the FDA said.
Most affected children have impaired intellect, developmental delays and behavioral problems, the agency added.
Since the condition affects fewer than 200,000 people in the United States, the medication was given the agency's so-called "orphan drug" status. Common adverse reactions observed during clinical testing included sedation, fever, drooling, constipation, cough, urinary tract infection, insomnia, aggression, irritability, vomiting, swallowing problems, bronchitis and pneumonia, the FDA said.
As with other antiepileptic drugs, Onfi may increase the risk of suicidal thoughts and behaviors in a small number of users, the agency warned. All users should be carefully monitored for these symptoms, the FDA said.
The drug may also cause sedation, so older users shouldn't drive or use heavy machinery. Onfi has been categorized as a Schedule IV drug under the Controlled Substances Act, the FDA said.
The drug is manufactured by Catalent Pharma Solutions, based in Winchester, Ky.
-- Scott Roberts
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