Navigation Links
FDA Advisers Don't Back 'Black Box' Warning for Epilepsy Drugs
Date:7/10/2008

Experts do find 11 anti-seizure drugs heighten suicide risk, and they recommend medication guide for doctors

THURSDAY, July 10 (HealthDay News) -- Anti-seizure drugs can cause increased suicidal tendencies in patients, but not enough to warrant the government's strongest warning label on them, a U.S. health advisory panel concluded Thursday.

The 20-member panel did vote unanimously, with one abstention, to back the scientific findings on 11 antiepileptic drugs studied by the U.S. Food and Drug Administration.

In late January, the FDA announced it was considering a black box warning after an agency review of 199 studies comparing the drugs, which are used by millions, to placebos. That review found that patients taking the drugs had about twice the risk of suicidal behavior compared with patients taking a placebo.

"We have concluded this was a real signal, and the signal applied to all drugs we studied," Dr. Russell Katz, director of the division of neurology products at the FDA's Center for Drug Evaluation and Research, told reporters at a late-afternoon teleconference Thursday.

"We propose that labels for all these antiepileptic drugs be changed to include a box warning, and patients should be given a medication guide describing these events with each prescription refill," he said.

On Thursday, the advisory panel appeared to agree with him -- up to a point. It voted in favor of sending a medication guide to doctors detailing the suicide risks.

But a majority of panel members voted against adding the black box warning, saying the studies didn't show a high enough risk for suicidal behavior.

"The general view of the committee was concern that patients or physicians would not prescribe these drugs in certain circumstances where they should," Katz said. "The committee voted 14 'no, it should not be described in a box warning, although it should be described in the label somewhere.' There were four 'yes' votes and three abstentions."

Whether the FDA will follow the committee's recommendation against a black box warning will be a matter of discussion, Katz added.

"We take the committee's recommendations very seriously," he said.

The drugs reviewed by the FDA were: Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR), Felbamate (marketed as Felbatol), Gabapentin (marketed as Neurontin), Lamotrigine (marketed as Lamictal), Levetiracetam (marketed as Keppra), Oxcarbazepine (marketed as Trileptal), Pregabalin (marketed as Lyrica), Tiagabine (marketed as Gabitril), Topiramate (marketed as Topamax), Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon) and Zonisamide (marketed as Zonegran). Some of these drugs are also available as generics.

According to the FDA, antiepileptic drugs are used to treat epilepsy, bipolar disorder, migraine headaches and other conditions.

In January, the FDA was advising patients not to make any changes in their medication without talking to their doctor.

"Caregivers should pay close attention to changes in mood, behavior and actions," FDA spokeswoman Sandy Walsh said at the time. "They should be aware of the development of these symptoms."

More information

For more on epilepsy, visit the Epilepsy Foundation.



SOURCES: July 10, 2008, teleconference with Russell Katz, M.D., director, division of neurology products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Md.; Sandy Walsh, spokeswoman, FDA


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Advisers Urge Ban on Cold Medicines for Young Children
2. U.S. Advisers OK Nasal Spray Flu Vaccine for Young Children
3. FDA Advisers Reject Over-the-Counter Statin
4. FDA Advisers Dont Back Epilepsy Drug Warnings
5. Growing Link Between Diabetes and Periodontal Disease Focus of National Gathering for Health Care Leaders
6. Treating your periodontal pockets may benefit your pocket book
7. Ortho Organizers(R) Announces the Launch of the Ancor Pro(TM) Orthodontic Anchorage System Hands-on Course
8. Survey confirms Americans prefer root canal treatment by endodontists
9. Most With High Blood Pressure Dont Follow Recommended Diet
10. Watch Your Mouth: Michigan Association of Endodontists Offers Four Part Series on Keeping Your Teeth Healthy
11. NYU dental researchers find evidence of periodontal disease leading to gestational diabetes
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Advisers Don't Back 'Black Box' Warning for Epilepsy Drugs
(Date:9/20/2017)... ... September 20, 2017 , ... The ... “Humans With Vaginas.” The goal is to ignite conversation via social media and ... products. The brand has declared September “Humans with Vaginas” month, releasing a video ...
(Date:9/20/2017)... , ... September 20, 2017 , ... ... of older Americans at risk of price gouging for their prescription drugs, according ... (TSCL) . “Because Medicare isn’t negotiating on our behalf, there’s no consistency in ...
(Date:9/20/2017)... ... , ... “The Trials I Face to Receive God’s Grace”: a mesmerizing ... and goals to better one’s life through God. “The Trials I Face to Receive ... the wrong places, found a love for writing. Green feels that expressing his feelings ...
(Date:9/20/2017)... Texas (PRWEB) , ... September 20, 2017 , ... Houston, ... entire team took Friday, September 8, and Monday, September 11, off work and rolled ... Second Baptist Church before heading to local homes to start the process of rebuilding. ...
(Date:9/20/2017)... ... 2017 , ... “The Foggy Road to Moorwick”: the adventures of a young Scottish girl yearning ... author, Jeanine Liston, a busy mother of five who used her time waiting for children ... book for over twenty years. It was a way to give some meaning to ...
Breaking Medicine News(10 mins):
(Date:9/7/2017)... Sept. 7, 2017  For nearly two decades, New Life Agency has ... Reproduction Insurance industry. Today, New Life Agency announces a powerful three-way partnership ... ... ... http://pharmacarecard.com/ (PRNewsfoto/PharmaCareCard) ...
(Date:9/7/2017)... --  BioLife Solutions , Inc. (NASDAQ: BLFS ), ... cell and tissue hypothermic storage and cryopreservation ... President and CEO, will be presenting at two investment conferences ... 19 th Annual Global Investment Conference on Tuesday, September ... The conference is being held at the New York Palace ...
(Date:9/6/2017)... 6, 2017 NeuroRx, a clinical stage biopharma company ... Behavior (ASIB), has been granted Fast Track status by the ... NRX-100 (ketamine HCl) followed by NRX-101 (D-cycloserine + lurasidone). The ... of this sequential therapy targeting patients who are admitted to ... ...
Breaking Medicine Technology: