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An analysis of suicidal and self-injurious behavior reports with antiseizure medications in the FDA adverse event database.
Porwal, Mokshal H; Razzak, Abrahim N; Kumar, Vinay; Obeidat, Ahmed Z; Sharma, Umesh.
Afiliación
  • Porwal MH; 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.
  • Razzak AN; Department of Neurology, Medical College of Wisconsin, 8701 W Watertown Plank Rd, Milwaukee, WI 53226, USA. Electronic address: arazzak@mcw.edu.
  • Kumar V; Department of Neurology, Temple University, 1801 N Broad St., Philadelphia, PA 19122, USA.
  • Obeidat AZ; Department of Neurology, Medical College of Wisconsin, 8701 W Watertown Plank Rd, Milwaukee, WI 53226, USA.
  • Sharma U; Department of Neurology, University of Central Florida, 4000 Central Florida Blvd, Orlando, FL 32816, USA.
Epilepsy Res ; 203: 107382, 2024 Jul.
Article en En | MEDLINE | ID: mdl-38761467
ABSTRACT

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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Conducta Autodestructiva / Sistemas de Registro de Reacción Adversa a Medicamentos / Anticonvulsivantes Límite: Adolescent / Adult / Aged / Child / Female / Humans / Male / Middle aged País/Región como asunto: America do norte Idioma: En Revista: Epilepsy Res Asunto de la revista: CEREBRO / NEUROLOGIA Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Conducta Autodestructiva / Sistemas de Registro de Reacción Adversa a Medicamentos / Anticonvulsivantes Límite: Adolescent / Adult / Aged / Child / Female / Humans / Male / Middle aged País/Región como asunto: America do norte Idioma: En Revista: Epilepsy Res Asunto de la revista: CEREBRO / NEUROLOGIA Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos