| アブストラクト | BACKGROUND: Pharmacovigilance systems such as the FDA Adverse Event Reporting System (FAERS), are established models for adverse event surveillance that may have been missed during clinical trials. We aimed to analyze twenty-five anti-seizure medications (ASMs) in FAERS to assess for increased reporting of suicidal and self-injurious behavior. METHODS: Twenty-five ASMs were analyzed: brivaracetam, cannabidiol, carbamazepine, clobazam, clonazepam, diazepam, eslicarbazepine, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, perampanel, phenobarbital, phenytoin, pregabalin, primidone, rufinamide, stiripentol, tiagabine, topiramate, valproate, vigabatrin, zonisamide. Reports of "suicidal and self-injurious behavior" were collected from January 1, 2004, to December 31, 2020, using OpenVigil 2.1 tool with indication as "Epilepsy". Relative reporting ratio, proportional reporting ratio, and reporting odds ratio were calculated utilizing all other drug reports for epilepsy patients as a control. RESULTS: Significant relative operating ratio, ROR (greater than 1, p<0.05) were observed for diazepam (2.909), pregabalin (2.739), brivaracetam (2.462), gabapentin (2.185), clonazepam (1.649), zonisamide (1.462), lacosamide (1.333), and levetiracetam (1.286). CONCLUSIONS: Of the 25 ASMs that were analyzed in this study, 4 (16%) were identified to have been linked with a likely true adverse event. These drugs included diazepam, brivaracetam, gabapenetin, and pregabalin. Although several limitations are present with the FAERS database, it is imperative to closely monitor patient comorbidities for increased risk of suicidality with the use of several ASMs. |
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| 組織名 | Department of Neurosurgery, Allegheny General Hospital, 320 E North;Ave, Pittsburgh, PA 15212, USA; Department of Neurology, Medical College of;Wisconsin, 8701 W Watertown Plank Rd, Milwaukee, WI 53226, USA.;Department of Neurology, Medical College of Wisconsin, 8701 W Watertown Plank;Rd, Milwaukee, WI 53226, USA. Electronic address: arazzak@mcw.edu.;Department of Neurology, Temple University, 1801 N Broad St., Philadelphia, PA;19122, USA.;Rd, Milwaukee, WI 53226, USA.;Department of Neurology, University of Central Florida, 4000 Central Florida;Blvd, Orlando, FL 32816, USA. |
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