FDA: Epilepsy Drugs Should Carry Suicidal Warning
By Anna Boyd
13:51, July 8th 2008
32 votes
Vote this story
FDA: Epilepsy Drugs Should Carry Suicidal Warning

The U.S. Food and Drug Administration says epilepsy drugs should carry a “black box” warning about the risk of suicidal thoughts and behavior.

The proposal has been released ahead of a meeting to be held on Thursday in which a panel of outside experts will discuss risks with drugs to treat the disease, which manifest by seizures that can cause involuntary movement or behavior.

According to government estimates, roughly 2.7 million Americans have epilepsy.

The FDA said all 11 epilepsy drugs included in the study should carry the black box warning, although three of them showed no clear sign of suicidal problems.

The FDA analysis on 199 studies found that 0.43 percent of patients on epilepsy drugs killed themselves or thought about doing so, compared with 0.24 percent of patients on a placebo.

GlaxoSmithKline Plc’s Lamictal and Pfizer Inc’s Lyrica are among the top-selling epilepsy drugs.

Others include Johnson & Johnson’s Topamax and Abbott Laboratories Inc’s Depakote. Additional drugs included in the FDA’s review are Pfizer’s Neurontin, Meda AB’s Felbatol, UCB SA’s Keppra, Novartis AG’s Trileptal, Cephalon Inc.’s Gabritil, Eisai Co.’s Zonegran and carbamazepine sold by several drug makers.

These drugs are also used for migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder.

“We are going to ask for a boxed warning on these drugs,” FDA representative Sandy Walsh said on Monday, according to Reuters.

“There seems to be no compelling reason to: 1) ignore what appears to be a very clear empirical finding of an increase in suicidality, despite no obvious explanation for this finding, or 2) not generalize the conclusion to other (anti-epilepsy drugs),” Dr. Russell Katz, head of the FDA's division of neurology products wrote in the memo addressed to the panel.

 

 



© 2007 - 2008 - eFluxMedia
Share the News:
Del.icio.us Digg Stumble Upon Facebook Newsvine Mixx
dotclear

Other News in

Cold Medicine Undergoes Relabeling

Cold Medicine Undergoes Relabeling

Tuesday, the drug industry has announced that over-the-counter (OTC) cough and cold medicine was to be relabeled in order to warn against it being used on children under the age of...

Safer Test For Down Syndrome In Fetuses

Safer Test For Down Syndrome In Fetuses

Presently, pregnant women that are worried about their baby suffering from Down syndrome have to undergo procedures that require a needle to be implanted into the uterus. These procedures, though...

Using Fans Might Reduce Risk of SIDS

Using Fans Might Reduce Risk of SIDS

On Monday, researchers reported that the use of a fan to circulate air in babies’ rooms has been linked to decreased risk of Sudden Infant Death Syndrome. The study revealing the...

Colorectal Cancer Screenings Should Stop at Age 75, Government Task Force Recommends

Colorectal Cancer Screenings Should Stop at Age 75, Government Task Force Recommends

The U.S. Preventive Services Task Force has rejected the latest X-ray screening technology, called CT colonography, saying that more research is needed. The government task force also said everyone...

Fan in Baby’s Room Found to Reduce SIDS Risk

Fan in Baby’s Room Found to Reduce SIDS Risk

New research found fans were associated with a 94% reduction in SIDS risks for infants who slept in rooms that exceeded 70 degrees (21 degrees C) and an 84% reduction for babies who slept in...

dotclear
Latest videos in Health
Toxic milk alert hits South...
Tainted Milk Scandal Spreads...
India bans public smoking
Poor Ratings Cited for 13...
China mums urged to breastfeed

dotclear
Health You are here: Health
» Science   » Health   
E-mail To A Friend Print RSS Text size: Decrease font size Increase font size
dotclear
dotclear
dotclear
Most Popular in Health
Leading Emory Psychiatrist ‘Fails’ to Report $1.2 Million of Drug IncomeLeading Emory Psychiatrist ‘Fails’ to Report $1.2 Million of Drug Income

» read full story
dotclear

Interested In This Topic?

News Alert will keep you informed. Find out more.
dotclear
Photos Gallery
dotclear
Today's Latest News
Bernanke suggests rate cut as Fed announces new liquidity measures

» read full story
dotclear