Relationship Between Antiepileptic Drugs and Suicide Attempts in Patients With Bipolar Disorder
Open Access
- 1 December 2009
- journal article
- research article
- Published by American Medical Association (AMA) in Archives of General Psychiatry
- Vol. 66 (12) , 1354-1360
- https://doi.org/10.1001/archgenpsychiatry.2009.159
Abstract
Anticonvulsant medications are life saving in the treatment of seizure disorders and are also extensively used for other indications such as mood disorders and trigeminal neuralgia. In March 2005, the Food and Drug Administration (FDA) sent letters to sponsors of 11 antiepileptic drugs (AEDs) requesting the submission of suicidality data from randomized clinical trials. The data consisted of suicide-related adverse event reports and a search for suicide-related terms in electronic databases related to the studies. The 11 AEDs included gabapentin, divalproex, felbamate, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine, topiramate, zonisamide, and carbamazepine. The FDA1 conducted a meta-analysis of 199 placebo-controlled trials that included 43 892 patients (27 863 in drug-treatment groups and 16 029 in placebo). A total of 0.43% of the patients in drug treatment groups reported suicidal behavior or ideation vs 0.22% of the patients in placebo groups. Compared with placebo controls, 2.1 per 1000 more treated patients (95% confidence interval [CI], 0.7-4.2) reported suicidal behavior or ideation. On January 31, 2008, the FDA issued an alert to health care providers warning of increased risk of suicidal thoughts and behavior related to AEDs.2 On July 10, 2008, the FDA's scientific advisory committee voted that there was a significant association between AEDs and suicidality but voted against a black box warning.Keywords
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