FDA approves Eisai drug for partial seizures
WASHINGTON (AP) — The Food and Drug Administration on Monday approved a new drug, Fycompa, for partial seizures caused by epilepsy.
The agency approved the Japanese drugmaker Eisai Inc.'s tablet for epilepsy patients 12 years of age and older. The disease is a brain disorder characterized by excessive nervous system activity, which can cause a variety of spasms, seizures and unusual behavior.
Partial seizures are the most common type of seizure experienced by people with epilepsy.
FDA officials said in a statement that it's important to have multiple medication options available for epilepsy patients, since some people do not respond to currently available drugs.
Fycompa will carry a boxed warning about potentially dangerous side effects, including aggression, anger, paranoia and anxiety. It advises patients and caregivers to alert their doctors if unusual changes in mood or behavior are observed.
Eisai Inc. is based in Tokyo, with U.S. operations in Woodcliff Lake, N.J.