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FDA alert regarding suicidality with AEDs receives low marks from neurologists; nearly half say it will not influence their practice

Wednesday, April 01 2009 | Comments

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What's This? Results of a recent survey suggest that the Food and Drug Administration alert about an increased risk of suicidality with antiepileptic drugs (AEDs) was not well-received by neurology practitioners, with 46% of the respondents stating that it would not influence their clinical practice.

The FDA issued an alert in January of last year stating that AEDs were associated with an increased risk of suicidal ideation and behavior, and that patients taking AEDs should be monitored for any relevant changes in behavior. To evaluate neurology practitioners' responses to the alert and to assess their attitudes toward the treatment of depression and suicidality in patients with epilepsy, researchers invited 780 members of the American Epilepsy Society to participate in an online survey; 175 (22%) completed the survey.

More than half of the respondents were affiliated with academic institutions (60%), practiced as part of a comprehensive epilepsy program (74%), devoted the majority of their clinical practice to epilepsy (58%), and had been practicing for >10 years (55%).

Regarding the respondents' general attitudes toward evaluating and treating depression, 62% said they do not use a metric scale such as the Beck Depression Inventory to screen for depression in patients with epilepsy, and 42% said they do not feel comfortable initiating treatment for depression. Almost all of the practitioners (98%) said they caution certain or all patients about behavioral side effects of AEDs when treatment is initiated, but only 44% said they warn patients about the increased risk of suicidality.

Forty-one percent of the respondents were aware of patients who had attempted suicide, and 18% were aware of patients who completed suicide.

The participants critiqued different aspects of the FDA alert using a scale that ranged from 1 to 10, with a higher score indicating a more positive opinion. On average, the alert received low marks for its clarity (mean score, 5.3), appropriateness (4.1), and impact on clinical practice (3.6). Nearly half of the respondents (46%) said they would not change their clinical practice as a result of the alert. Among those who said it would affect their practice, most preferred to counsel patients individually regarding the alert. Ninety-six percent of the respondents did not think there was a need to send letters to all of their patients about the alert.

In a section of the survey that allowed for open-ended comments, most comments reflected frustration and unhappiness with the alert, the authors noted. For example, some respondents were concerned by the way in which the FDA presented and analyzed the data (n=13) and some were concerned about potential adverse effects of the alert, including reduced patient compliance (n=9) and increased legal litigation (n=5). In other comments, physicians stated that suicide in patients with epilepsy is related primarily to comorbid psychiatric conditions rather than epilepsy or AEDs (n=11) or that the suicide rate in patients with epilepsy is low or is not an issue (n=9). Two comments identified a single AED that might be linked with suicidality in these patients. (Shneker BF, et al. Neurology 2009;72:987-991.)

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