FDA Alert on Suicidality Risk With Antiepileptics Not Well Rated


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NEW YORK (Reuters Health) Apr 01 - Neurology practitioners did not respond
well to the Food and Drug Administration's alert concerning suicidality and
antiepileptic drugs, according to survey results published in the March 17th
issue of Neurology.
"On January 31, 2008, the US Food and Drug Administration (FDA) issued an
alert regarding antiepileptic drugs (AEDs) and suicidality (defined as
suicidal ideation and behavior)," Dr. Bassel F. Shneker and colleagues from
the Ohio State University, Columbus, explain.
"The alert recommends monitoring patients starting or taking AEDs for any
changes in behavior that could indicate suicidality," they note. "The
analysis of clinical trials of 11 AEDs showed that patients taking these
AEDs had approximately twice the risk of suicidal behavior or ideation
compared to patients receiving placebo (0.43% versus 0.22%)."
To determine neurology practitioners' reaction to the FDA alert, as well as
the practitioners' opinions about suicidality and depression in patients
with epilepsy, the team developed a 21-question survey. A total of 780
subjects were invited via email to respond to the online survey, and 175
(22%) completed the survey. Most of those who responded were epilepsy
specialists practicing in academic settings.
Approximately 62% of respondents did not use any formal scale to screen
patients for comorbid depression, and about 42% of participants were not
comfortable initiating treatment for depression, the investigators report.
While 98% of practitioners discussed behavioral side affects with patients
starting AEDs, only 44% talked specifically about suicidality. Only 41% of
participants reported being aware of epilepsy patients who attempted to
commit suicide, and only 18% reported that they were aware of patients who
had committed suicide.
On scales of 1 - 10, the FDA alert received low scores in terms of clarity
(5.3), appropriateness (4.1), and impact on clinical practice (3.6).
"Almost half of the participants (46%) reported that the FDA alert will not
affect their clinical practices," Dr. Shneker and colleagues report. "For
those whose practices will be affected, the majority will do counseling
about suicidality and AEDs whenever starting an AED for any indication."
The investigators point out that patients with epilepsy have to take AEDs
regardless of the risk. Therefore, practitioners must be vigilant about
detecting signs of suicidality, and counsel patients appropriately.
Neurology 2009;72:987-991.

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