Navigation Links
FDA Advisers Don't Back Epilepsy Drug Warnings
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 voted unanimously, with one abstention, to back the 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 abstensions."

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, said spokeswoman Sandy Walsh.

"Caregivers should pay close attention to changes in mood, behavior and actions," she said. "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, Ddivision 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. Growing Link Between Diabetes and Periodontal Disease Focus of National Gathering for Health Care Leaders
5. Treating your periodontal pockets may benefit your pocket book
6. Ortho Organizers(R) Announces the Launch of the Ancor Pro(TM) Orthodontic Anchorage System Hands-on Course
7. Survey confirms Americans prefer root canal treatment by endodontists
8. Most With High Blood Pressure Dont Follow Recommended Diet
9. Watch Your Mouth: Michigan Association of Endodontists Offers Four Part Series on Keeping Your Teeth Healthy
10. NYU dental researchers find evidence of periodontal disease leading to gestational diabetes
11. HPV, periodontitis work in tandem to increase risk of tongue cancer
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Advisers Don't Back Epilepsy Drug Warnings
(Date:3/27/2017)... ... March 27, 2017 , ... ... gain site attention and engagement over the household brands of Top-20 pharma by ... will discuss how partnering with the right outsourcing payments provider can provide the ...
(Date:3/27/2017)... ... March 27, 2017 , ... ... behind the New England Journal of Medicine and NEJM Journal Watch, announces the ... Board Review was created by a panel of pediatricians from leading medical centers. ...
(Date:3/27/2017)... ... March 27, 2017 , ... Metabolism ... program at Women’s Excellence will help patients lose weight and keep it off. ... The specialists at Women's Excellence will measure BMI, body fat composition, and Calcium ...
(Date:3/27/2017)... ... ... is still in shock after receiving a $2,500 Academic Award from California Casualty . ... , She thinks the coming week is going to be a very joyful for her ... my students.” , The award will allow the 4th grade teacher at Tumwater Hill Elementary ...
(Date:3/27/2017)... , ... March 27, 2017 , ... ... a settlement agreement to resolve the pending litigation between itself and 1800 Vending ... District of Utah). , “I am thrilled to announce that we have now ...
Breaking Medicine News(10 mins):
(Date:3/27/2017)... 27, 2017 To mark the end of Save ... a leader in digital imaging solutions, will showcase Canon eye ... at New York,s Jacob Javits Center ... Month, sponsored by the American Optometric Association, is observed annually ... receiving comprehensive eye exams. In recognition of this observance, Canon ...
(Date:3/27/2017)... March 27, 2017 FinancialBuzz.com News Commentary  ... According to a new report by Arcview ... , grew 34 percent to $6.7 billion and can be expected ... over the next five years, from $6.7 billion in 2016, to $22.6 ... will be able to purchase cannabis without a doctor,s recommendation. Voters in ...
(Date:3/27/2017)... March 27, 2017  BERG, a biopharmaceutical ... biological research approach, today announced that the ... discovery of new data using a cold-induced ... fat metabolism. Joslin Diabetes Center led the ... platform for analysis of samples.  The findings ...
Breaking Medicine Technology: