HealthDay News — The FDA has approved Fycompa (perampanel, Eisai Inc.) tablets to treat partial onset seizures in individuals aged 12 years and older who have epilepsy, after results from three clinical trials show the drug improved seizure control compared with placebo in this population.
Partial onset seizures are the most common type among people with epilepsy, the agency said in a press release. These types of seizures affect only a limited or localized area of the brain, but can spread to other parts of the brain, causing repetitive limb movements (spasms), unusual behavior and generalized convulsions with loss of consciousness.
The most common side effects of Fycompa reported during clinical trials include: dizziness, drowsiness, fatigue, irritability, falls, upper respiratory tract infection, weight increase, vertigo, ataxia, gait disturbance, balance disorder, anxiety, blurred vision, dysarthria, asthenia, aggression and hypersomnia.
Fycompa’s label will include a boxed warning to alert prescribers and patients about the risk of serious neuropsychiatric events including irritability, aggression, anger, anxiety, paranoia, euphoric mood, agitation and mental status changes.