Onfi Approved to Treat Severe Seizures10/24/11
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
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
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
Visit the U.S.
National Institute of Neurological Disorders and
Stroke to learn more about Lennox-Gastaut syndrome.
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