Authors :
Presenting Author: Amanda Pong, MD, MSc – Mid-Atlantic Epilepsy and Sleep Center, Comprehensive Epilepsy Clinics of Bethesda
Kevin Xu, BS, BS – Mid-Atlantic Epilepsy and Sleep Center, Mid-Atlantic Neurological Institute, Bethesda, MD; Dylan Huynh, BS – Mid-Atlantic Epilepsy and Sleep Center, Mid-Atlantic Neurological Institute, Bethesda, MD; Alexander Giermek, BS – Mid-Atlantic Epilepsy and Sleep Center, Mid-Atlantic Neurological Institute, Bethesda, MD; Pavel Klein, M.B., B.Chir. – Mid-Atlantic Epilepsy and Sleep Center, Mid-Atlantic Neurological Institute, Bethesda, MD
Rationale:
Although new anti-seizure medications (ASMs) demonstrate good safety and tolerability, they have come under great scrutiny as agents of potential abuse. Currently, any depressant, stimulant or hallucinogenic effects noted in human abuse potential studies (HAPS) performed with known drug users are translated into potential for abuse in people with epilepsy (PWE). [1] Based on this methodology, pregabalin (PGB), lacosamide (LCM), brivaracetam (BRV), and cenobamate (CNB) are Schedule V and perampanel (PER) Schedule III drugs. This study aims to describe real-world reports of abuse/dependence of new ASMs in PWE, for whom these drugs are prescribed for epilepsy treatment, in comparison to known drugs with abuse/dependence potential. Specifically, do FAERS data support the scheduling of many new ASMs as drugs of increased risk of abuse/dependence?
Methods:
New FDA-approved ASMs include LCM 2010, eslicarbazepine (ESL) 2013, PER 2014, BRV 2016, cannabidiol (CBD) 2018, CNB 2020, fenfluramine (FFA) 2020. Key terms of the MedDRA Hierarchy-controlled vocabulary indicating abuse/dependence were reported from FAERS for new ASMs (approval to 2022), and comparitors of known abuse potential (2020-2022): gabapentin (GBP), pregabalin (PGB), and alprazolam.
Results:
42,454 total adverse event reports were reviewed: LCM=18319, ESL=1657, PER=3205, BRV=3372, CBD =12610, CNB=2216, FFA=1075.
Abuse/total reports: LCM 0.142% (n=26); ESL 0.060% (n=1); PER 0.218% (n=7); BRV 0.030% (n=1); CBD 0.032% (n=4); CNB 0% (n=0); FFA 0% (n=0).
Dependence/total reports: LCM 0.066% (n=12); ESL 0.060% (n=1) ; PER 0.062% (n=2); BRV 0.089% (n=3); CBD 0.008% (n=1); CNB 0% (n=0); FFA 0% (n=0).
Comparitor results for abuse/dependence:
Alprazolam (14,875): 18.313% (n=2724); 10.319% (n=1535).
PGB (28,345): 5.317% (n=1507); 3.179% (n=901)
GBP (19,119): 18.562% (n=1030); 2.605% (n=498)
Conclusions:
Our analyses showed overall low (<