Featured Research

from universities, journals, and other organizations

Epilepsy Drugs: Doctors Raise Questions, Concerns About FDA Suicide Warning

Date:
December 18, 2008
Source:
American Epilepsy Society
Summary:
Among the doctors' concerns is that news reports of the FDA's analyses have confused patients and, perhaps, some physicians on the risks associated with epilepsy drugs. They cite data showing that the risk of suicide possibly associated with anti-epileptic drugs (AEDs) is extremely small compared to the potential danger of leaving patients untreated. Also of concern is that epilepsy patients prone to suicidal ideation or behavior will be excluded from clinical trials of new AEDs.

Medical specialists at the nation's largest professional meeting on epilepsy discussed multiple questions and concerns they have about data presented by the FDA in support of its recent suicide alert on anticonvulsant drugs (AEDs) and the potential effect of the federal agency's analyses on clinical practice and the way AED drug trials are to be conducted in the future.

Related Articles


It is well known that non-adherence to antiepileptic drug therapy can lead to a dramatic increase in accidents and deaths. For these reasons, epileptic experts believe it is imperative that patients continue their antiepileptic therapy to prevent the occurrence of serious accidents and death.

During the American Epilepsy Society's annual meeting, epidemiologists, epileptologists and psychiatrists offered a critical review of the FDA's methodology and analyses, describe the suicide alert's potential impact on patient compliance and seizure management, and its likely effect on the selection of patients for AED regulatory studies.

Among the doctors' concerns is that news reports of the FDA's analyses have confused patients and, perhaps, some physicians on the risks associated with epilepsy drugs. They cite data showing that the risk of suicide possibly associated with AEDs is extremely small compared to the potential danger of leaving patients untreated. Also of concern is that epilepsy patients prone to suicidal ideation or behavior will be excluded from clinical trials of new AEDs.

The panel is seriously concerned about methodological flaws in the FDA's data collection and analysis, including biased measurement of suicidality and exclusion of a large proportion of the data. The FDA performed similarly flawed analysis of the SSRIs. After the black box warning appeared, there was a decrease in use of the SSRIs with a corresponding increase in suicide, contrary to what the FDA's conclusions would predict.

The discussion by leading experts was headed by Andres M. Kanner, M.D., professor of neurological sciences at Rush Medical Center and associate director of the Rush Epilepsy Center. The other panelist for the session, titled Suicidality and Epilepsy: A Complex Problem, are Dr. Hesdorffer (Columbia University), Anne T. Berg, Ph.D. (Northern Illinois University), John J. Barry, M.D. (Stanford University), Rochelle Caplan, M.D. (UCLA), and Jacqueline A. French, M.D. (New York University).


Story Source:

The above story is based on materials provided by American Epilepsy Society. Note: Materials may be edited for content and length.


Cite This Page:

American Epilepsy Society. "Epilepsy Drugs: Doctors Raise Questions, Concerns About FDA Suicide Warning." ScienceDaily. ScienceDaily, 18 December 2008. <www.sciencedaily.com/releases/2008/12/081209125826.htm>.
American Epilepsy Society. (2008, December 18). Epilepsy Drugs: Doctors Raise Questions, Concerns About FDA Suicide Warning. ScienceDaily. Retrieved March 29, 2015 from www.sciencedaily.com/releases/2008/12/081209125826.htm
American Epilepsy Society. "Epilepsy Drugs: Doctors Raise Questions, Concerns About FDA Suicide Warning." ScienceDaily. www.sciencedaily.com/releases/2008/12/081209125826.htm (accessed March 29, 2015).

Share This


More From ScienceDaily



More Mind & Brain News

Sunday, March 29, 2015

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

AAA: Distracted Driving a Serious Teen Problem

AAA: Distracted Driving a Serious Teen Problem

AP (Mar. 25, 2015) While distracted driving is not a new problem for teens, new research from the AAA Foundation for Traffic Safety says it&apos;s much more serious than previously thought. (March 25) Video provided by AP
Powered by NewsLook.com
Smartphone Use Changing Our Brain and Thumb Interaction, Say Researchers

Smartphone Use Changing Our Brain and Thumb Interaction, Say Researchers

Reuters - Innovations Video Online (Mar. 25, 2015) European researchers say our smartphone use offers scientists an ideal testing ground for human brain plasticity. Dr Ako Ghosh&apos;s team discovered that the brains and thumbs of smartphone users interact differently from those who use old-fashioned handsets. Jim Drury went to meet him. Video provided by Reuters
Powered by NewsLook.com
Many Don't Know They Have Alzheimer's, But Their Doctors Do

Many Don't Know They Have Alzheimer's, But Their Doctors Do

Newsy (Mar. 24, 2015) According to a new study by the Alzheimer&apos;s Association, more than half of those who have the degenerative brain disease aren&apos;t told by their doctors. Video provided by Newsy
Powered by NewsLook.com
A Quick 45-Minute Nap Can Improve Your Memory

A Quick 45-Minute Nap Can Improve Your Memory

Newsy (Mar. 23, 2015) Researchers found those who napped for 45 minutes to an hour before being tested on information recalled it five times better than those who didn&apos;t. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins