The U.S. Food and Drug Administration (FDA) warned healthcare professionals that patients taking antiepileptic drugs (AEDs) have twice the risk of suicidal behavior or ideation compared with those taking placebo. A yet unpublished analysis of data from 199 placebo-controlled studies of 11 AEDs indicated that 0.43% of the AED group experienced suicidal behavior or ideation compared to 0.22% of the placebo group. In the 27,863 AED patients, there were 105 reports of suicidal symptoms and 4 completed suicides com- pared to 35 reports of suicidal symptoms and 0 suicides in the placebo group. This effect was seen in as little as 1 week, and the relative risk versus placebo was higher in epilepsy patients (RR= 3.6) than in psychiatric patients (RR= 1.6) (accessed online at http://www.fda.gov/cder/drug/ InfoSheets/HCP/antiepilepticsHCP.htm).
TCPR’s Take: It appears that AEDs roughly double the risk of suicidality as compared with placebo. However, the absolute risks are small, and the effect appears more likely in patients treated for epilepsy than for patients with psychiatric illness (although the FDA has yet to publish all the data required to compare these two populations). Given the small absolute risks, this finding likely won’t affect AED prescribing for bipolar disorder or epilepsy, but it encourages us to think twice before prescribing AEDs for less established off-label indications, like anxi- ety disorders.
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