Mood and Behavioral Adverse Events of Antiseizure Medications as a Surrogate Marker for Assessing the Risk of Antiseizure Medication Related Suicidality
Abstract number :
2.403
Submission category :
7. Anti-seizure Medications / 7D. Drug Side Effects
Year :
2024
Submission ID :
497
Source :
www.aesnet.org
Presentation date :
12/8/2024 12:00:00 AM
Published date :
Authors :
Presenting Author: Koushalya Sachdev, BBA – John Sealy School of Medicine at The University of Texas Medical Branch
Sriprasad Aditya Vikram, BS, MPH – VA Greater Los Angeles Healthcare System
Alexander Crossley, BA, MPH – VA Greater Los Angeles Healthcare System
Devina Pande, MBBS – K J Somaiya Medical College, Maharashtra University of Health Sciences
Harikrishan Sachdev, BBA – Texas Tech University Health Sciences Center School of Medicine
Sharda Spitz, BS – California Polytechnic State University--San Luis Obispo
Divya Singh, Student – VA Greater Los Angeles Healthcare System
Sunita Dergalust, PharmD, BCPS – VA Greater Los Angeles Healthcare System
Rationale: In 2008, the US Food and Drug Administration (FDA) mandated a class label warning for increased suicidality risk for all antiseizure medications (ASMs). This warning was based on a meta-analysis comparing suicidality between individuals treated with ASMs vs placebo in randomized clinical trials completed prior to 2008. Increased risk of suicidality was associated with 8 out of 11 ASMs, with topiramate (TPM) and lamotrigine (LTG) reaching statistical significance. The FDA indicated that suicidality symptoms may potentially be associated with other psychiatric adverse events. Since then, multiple retrospective cohort studies and case-controlled studies on the risk of suicidality explored whether or not there is an association between ASMs and the risk of suicidal ideation and behavior; however, results have been inconsistent. A case-controlled study published in 2010 indicated that newer ASMs (levetiracetam (LEV), tiagabine, (TGB), vigabatrin (VGB) and TPM) are associated with a high potential to cause depression, leading to a 3-fold increase in risk of suicidal behavior as compared to no use over the past year (Andersohn 2010). Most physicians and other healthcare professionals routinely obtain safety and efficacy information from prescriber information sheets (PIs) that are based on pivotal clinical trial data. Therefore, we reviewed PIs of all approved ASMs for the incidence of mood and behavioral adverse events that might contribute to an increased risk of suicidality due to the use of ASMs reported in the literature.
Methods: Incidence of mood and behavioral adverse events were collected from PIs of all ASMs approved in the United States. We are currently reviewing the literature for data on ASM related suicidality.
Results: Adverse events that occurred at an incidence of > 2% are reported in the PIs. When reviewing for incidence of mood and behavioral adverse events for 29 ASMs currently available in the U.S. market, we found the following: aggression was reported with use of perampanel (PER), rufinamide (RUF), clobazam (CLB), cannabidiol (CBD) and stiripentol (STP); anger with use of CBD and PER; anxiety with use of PER, RUF, VGB, LEV, LTG, felbamate, zonisamide (ZNS); irritability with use of PER, CLB, CBD, LTG, VGB ZNS, brivaracetam, fenfluramine; mood changes with use of PER; and agitation with use of CBD, STP, ZNS and oxcarbazepine.
Conclusions: : There is a significant information gap regarding the incidence of mood and behavioral adverse events reported in the PIs. We are continuing to collect data on the risk of ASM related suicidality.
Funding: None
Anti-seizure Medications