FORUM FOR PSYCHIATRY RESIDENTS
Would you like to react to this message? Create an account in a few clicks or log in to continue.
Follow Forum_Psych on Twitter
Search
 
 

Display results as :
 


Rechercher Advanced Search

Statistics
We have 222 registered users
The newest registered user is raheelmemon

Our users have posted a total of 1140 messages in 613 subjects
If you are seeing this, you have attempted to link to the UpToDate widget but are experiencing a problem. Please visit UpToDate for more information.
Share

FDA Approved Fycompa (Perampanel) to Treat Partial Onset Seizures

Go down

FDA Approved Fycompa (Perampanel) to Treat Partial Onset Seizures Empty FDA Approved Fycompa (Perampanel) to Treat Partial Onset Seizures

Post  Admin Mon Oct 22, 2012 7:51 pm

FDA Approved Fycompa (Perampanel) to Treat Partial Onset Seizures

For Immediate Release: Oct. 22, 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.”

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.
Admin
Admin
Admin
Admin

Posts : 948
Points : 2102
Reputation : 0
Join date : 2011-02-19
Location : Philadelphia

https://psychiatry.forumotion.com

Back to top Go down

Back to top

- Similar topics

 
Permissions in this forum:
You cannot reply to topics in this forum