Navigation Links
FDA Advisers Don't Back 'Black Box' Warning for Epilepsy Drugs

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:
Related Image:
FDA Advisers Don't Back 'Black Box' Warning for Epilepsy Drugs
(Date:11/27/2015)... ... November 27, 2015 , ... ... were," said an inventor from Hillside, N.J. "Many people catch diseases simply from ... that individuals will always be protected from germs." , He developed the patent-pending ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... through sharing, the 2016 Building Better Radiology Marketing Programs meeting will ... on Sunday, March 6, 2016, at Caesars Palace in Las Vegas with a ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... CBD ... Accreditation of Allied Health Education Programs (CAAHEP) awarded accreditation to its Diagnostic Medical Sonography ... CAAHEP accredited colleges, as only one of twelve colleges and universities in the state ...
(Date:11/26/2015)... ... November 26, 2015 , ... Patients at Serenity ... have come together on Thanksgiving Day to share the things that they are ... the Serenity Point YouTube channel, patients displayed what they wrote on index cards, ...
(Date:11/26/2015)... ... ... Jobs in hospital medical laboratories and in the imaging field lead the ... Aureus Medical Group . These fields, as well as travel nursing, ranked ... jobs through the company’s website, , The leading healthcare staffing agency ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 2015 ) ... "Radioimmunoassay Market by Type (Reagents & Kits, ... Clinical Diagnostic Labs), Application (Research, Clinical Diagnostics), ... report to their offering. --> ... of the "Radioimmunoassay Market by Type ...
(Date:11/25/2015)...  The total global healthcare industry is expected to grow ... Latin America has the highest projected growth at ... Japan ), is second with growth projected at 11.5%. ... healthcare expenditure. In 2013-2014, total government funded healthcare was nearly ... to 41.2% in 2013-2014. In real terms, out of pocket ...
(Date:11/25/2015)... , Nov. 25, 2015  Linden Care, LLC, ... optimizing treatment outcomes for patients suffering from chronic pain, ... for a Temporary Restraining Order (TRO) enjoining Express Scripts ... two companies. --> --> ... all of its legal options. --> ...
Breaking Medicine Technology: