Has the FDA's Alert Regarding AEDs and Suicidality Affected Clinical Practice?

SEATTLE—About 54% of health care professionals who treat patients with epilepsy indicated that they would change their practice following the FDA’s alert regarding an increased risk for suicidality with the use of antiepileptic drugs (AEDs), according to findings presented at the 62nd Annual Meeting of the American Epilepsy Society.

The FDA alert, issued in January 2008, was based on a retrospective analysis of 11 AEDs that were used in 199 placebo-controlled clinical trials of 43,892 patients 5 and older; 27,863 patients were treated with drugs and 16,029 with placebo. Suicidal behavior or ideation was nearly double in patients receiving AEDs (0.43%), compared with those receiving placebo (0.22%). Although the FDA’s analysis was based on 11 drugs, the agency extended the alert to all AEDs.

“We were interested in the response to the FDA alert,” said Jacquelyne Cios, MD, a Clinical Instructor of Neurology at Ohio State University in Columbus, and colleagues. “Would doctors counsel patients more, increase depression screening, and be more concerned about medical-legal risks?”

A total of 780 US clinicians who treat patients with epilepsy were invited to participate in the 21-question online survey; 175 (22%) responded. Most responders said they devote the majority of their practice to epilepsy (58%), work at a comprehensive epilepsy program (74%), practice in academic institutions (60%), and have practiced for more than 10 years (55%). Sixty-six (37.7%) clinicians use a metric scale to screen for depression.

Regarding their approach to counseling patients, 44% reported that they discuss suicidality when starting a patient on an AED, 16% when beginning certain AEDs, 15% for all AEDs, 9% among patients with comorbid mental illness, and 4% among patients with comorbid mental illness for certain AEDs. However, nearly all (98%) discuss possible behavioral effects of AEDs.

About 17% of clinicians said they ask all patients about suicidality, but 47% ask about suicidality in patients with depression, 26% ask if patients report being sad, and 10% discuss suicidality when it is brought up by the patient. In patients who have depression, 58% of clinicians initiate treatment, while 42% prefer that depression treatment be initiated by other practitioners.

Forty-six percent of physicians said the FDA’s alert would not change their practice. Twenty-five percent said that they would counsel patients about suicidality when starting any AED, 13% would counsel patients regarding certain AEDs, 11% would counsel patients who have a comorbid psychiatric condition, and 5% would counsel only patients with epilepsy. If their practice was to change in response to the alert, 46% said counseling would be “one on one,” and 8% said they would offer written material and counseling. Four percent would send all of their patients a written notice regarding the FDA alert.

On a scale of 1 to 10, the clinicians rated the FDA alert 5.3 for clarity (1 = very confusing; 10 = very clear), 4.1 for appropriateness (1 = not appropriate; 10 = very appropriate), and 3.6 for impact on practice (1 = no impact; 10 = significant impact). Clinicians were concerned about the validity of the study and afraid that patients’ compliance with AEDs would suffer as a result of the alert.