Suicide alert on epileptic drugs had little impact
NEW YORK (Reuters Health) - The U.S. Food and Drug Administration's alert on antiepileptics - drugs that control seizures -- can cause thoughts of suicide and suicidal behavior as a side effect, has received a minimal response by neurologists, according to survey results published recently published in the journal Neurology.
"On January 31, 2008, the U.S. Food and Drug Administration (FDA) issued an alert regarding antiepileptic drugs and suicidality," Dr. Bassel F. Shneker and colleagues from the Ohio State University, Columbus, explain.
"The alert recommends monitoring patients starting or taking antiepileptic drugs for any changes in behavior that could indicate suicidality," they note. "The analysis of clinical trials of 11 antiepileptic drugs showed that patients taking these antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation compared to patients receiving placebo (0.43 percent versus 0.22 percent)."
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 percent) completed the survey. Most of those who responded were epilepsy specialists practicing in academic settings.
Approximately 62 percent of respondents did not use any formal scale to screen patients for depression, and about 42 percent of participants were not comfortable initiating treatment for depression, the investigators report.
While 98 percent of practitioners discussed behavioral side affects with patients starting antiepileptic drugs, only 44 percent talked specifically about suicidality. Only 41 percent of participants reported being aware of epilepsy patients who attempted to commit suicide, and only 18 percent 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 percent) reported that the FDA alert will not affect their clinical practices," Shneker and colleagues report. "For those whose practices will be affected, the majority will do counseling about suicidality and antiepileptic drugs +whenever starting antiepileptic drugs for any indication."
The investigators point out that patients with epilepsy have to take antiepileptic drugs regardless of the risk. Therefore, practitioners must be vigilant about detecting signs of suicidality, and counsel patients appropriately.
SOURCE: Neurology 17, 2009.
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