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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.
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FULL STORY

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.

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 post is reprinted from 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 July 31, 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 July 31, 2015).

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