Monday, December 22, 2008

Doctors Raised Questions About FDA Epilepsy Drug Warning

Doctors Raise Questions-Concerns About FDA Suicide Warning

Epilepsy experts urge patients and caregivers to continue drug therapy

SEATTLE, December 8, 2008-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).

EDITOR'S NOTE: In addition to the panel presentation, the American Epilepsy Society submitted a letter to the FDA expressing its concern for potential misinterpretation by patients, families and physicians of package insert warnings.

About The American Epilepsy Society
The American Epilepsy Society (AES), based in West Hartford, CT, is among the oldest neurological professional organizations in the nation, with roots dating to 1898. The AES annual meeting is the world's preeminent professional meeting on epilepsy and attracts some 4,000 participants from around the globe. The Society promotes research and education for professionals (epileptologists) dedicated to the prevention, treatment and cure of epilepsy. Membership includes epilepsy clinicians, basic science and clinical investigators, and other health-care professionals interested in seizure disorders.

Information Contacts:
Peter Van Haverbeke
AES Media Relations
703-927-9639 mobile
802-375-9011 business