FDA Approves Fycompa – Side Effects

October 23, 2012 — The U.S. Food and Drug Administration today approved Fycompa (perampanel) tablets to treat partial onset seizures in patients with epilepsy ages 12 years and older.

“Some people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “It is important to have a variety of treatment options available for patients with epilepsy.”Partial seizures are the most common type of seizure seen in people with epilepsy. Epilepsy is a brain disorder in which there is abnormal or excessive activity of nerve cells in the brain. Partial seizures affect only a limited or localized area of the brain, but can spread to other parts of the brain. Seizures cause a wide range of symptoms, including repetitive limb movements (spasms), unusual behavior, and generalized convulsions with loss of consciousness.

Results from three clinical trials showed improvement in seizure control in patients taking Fycompa compared with those taking an inactive pill (placebo).

The most common adverse reactions reported by patients receiving Fycompa in clinical trials include: dizziness, drowsiness, fatigue, irritability, falls, upper respiratory tract infection, weight increase, vertigo, loss of muscle coordination (ataxia), gait disturbance, balance disorder, anxiety, blurred vision, stuttering (dysarthria), weakness (asthenia), aggression, and excessive sleep (hypersomnia).

Fycompa’s label has 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. Some of these events were reported as serious and life-threatening. Violent thoughts or threatening behavior was also observed in a few patients. Patients and caregivers should alert a health care professional immediately if changes in mood or behavior that are not typical for the patient are observed. Health care professionals should closely monitor patients during the titration period when higher doses are used.

Fycompa will be dispensed with a patient Medication Guide that provides important instructions on its use and drug safety information.

Fycompa is manufactured by Eisai Inc. of Woodcliff Lake, N.J.

Fycompa may cause other serious side effects, including:

  • Dizziness, vertigo (sense of spinning) and problems walking normally. You may have problems walking normally if you are unsteady because you feel dizzy. These symptoms can increase when your dose of Fycompa is increased. Your risk of feeling dizzy and having problems walking normally may be higher if you are elderly.
  • Sleepiness and tiredness. See What should I avoid while taking Fycompa?
  • Increased risk of falls. Taking Fycompa can increase your chance of falling. These falls can cause serious injuries. Your risk of falling may be higher if you are elderly.

The most common side effects of Fycompa include:

  • dizziness
  • sleepiness
  • tiredness
  • irritability
  • falls
  • nausea
  • problems with muscle coordination
  • problems walking normally
  • vertigo (sense of spinning)
  • weight gain

Tell your healthcare provider about any side effect that bothers you or does not go away.

These are not all of the possible side effects of Fycompa. For more information ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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