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:6/27/2016)... ... ... TherapySites, the leading website and online marketing ... Association. This new relationship allows TherapySites to continue to extend their online ... and promotional offers. , "TCA is extremely excited about this new partnership, as ...
(Date:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating to ... of individuals in the United States and Canada wear eyeglasses. Once considered to be ... vision and make a fashion statement. Even celebrities use glasses as a way of ...
(Date:6/26/2016)... ... ... Pixel Film Studios Released ProSlice Levels, a Media Slicing Effect Plugin ... whole new perspective by using the title layers in ProSlice Levels to split-up ... Levels contains over 30 Different presets to choose from. FCPX users can ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are ... with endometriosis. These women need a treatment plan to not only alleviate symptoms ... can help for preservation of fertility and ultimately achieving a pregnancy. The specialists ...
(Date:6/25/2016)... ... ... temporary closing of Bruton Memorial Library on June 21 due to a possible lice infestation, ... aspect of head lice: the parasite’s ability to live away from a human host, and ... necessary one in the event that lice have simply gotten out of control. , As ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Roche (SIX: ... 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) assay ... sepsis or septic shock. With this clearance, Roche is ... a fully integrated solution for sepsis risk assessment and ... with bacterial infection and PCT levels in blood can ...
(Date:6/23/2016)... , June 23, 2016 Bracket , ... launch its next generation clinical outcomes platform, Bracket eCOA (SM) ... held on June 26 – 30, 2016 in ... first electronic Clinical Outcome Assessment product of its kind to ... #715. Bracket eCOA 6.0 is a flexible platform ...
(Date:6/23/2016)... LONDON , June 23, 2016 ... environments  Oticon , industry leaders in ... the launch of Oticon Opn ™, the world,s ... world of possibilities for IoT devices.      ... Opn, Oticon introduces a number of ,world firsts,: ...
Breaking Medicine Technology: