Perampanel and Pregnancy (4272)

Objective: To summarize pregnancy and fetal/postnatal outcomes following maternal exposure to perampanel using clinical data. Background: Women with epilepsy frequently take anti-seizure medications (ASMs) during pregnancy, which requires balancing the benefits of maternal seizure control with potential risks to exposed fetuses. Perampanel is an ASM for focal and generalized tonic-clonic seizures; however, no adequate studies have assessed the developmental risk associated with perampanel use during pregnancy. Design/Methods: The global perampanel safety database, comprising reports of perampanel exposure during pregnancy in patients with and without epilepsy from spontaneous sources (routine clinical settings), interventional clinical studies, non-interventional post-marketing studies and other solicited sources (excluding the EURAP registry), was searched for events coded to MedDRA high-level group term of Pregnancy, Labor, Delivery and Postpartum Conditions and/or the Standardized MedDRA Query of Congenital, Familiar, and Genetic Disorders. Results: As of 31 August 2018, 99 pregnancies in 93 women exposed to perampanel had been reported. Sixty-two (66.7%) women reported receiving ≥1 concomitant ASM. Overall, 45 pregnancies reached full term (all normal live births), 28 did not reach term (induced abortion, n=18 [including hydatidiform mole, n=1; ectopic pregnancy, n=1]; spontaneous miscarriage, n=6; incomplete spontaneous miscarriage, n=2; stillbirth due to Fallot’s tetralogy, n=1; premature delivery, n=1), 19 were lost to follow-up, and 7 were ongoing at data cut-off. Adverse events were reported in five full-term neonates (low Apgar score [considered possibly related to perampanel by treating physician], n=2; fatal neonatal aspiration [not related to perampanel], n=1; cystic fibrosis and congenital deafness [not related to perampanel], n=1; poor sucking reflex and shallow breathing [considered possibly related to perampanel by treating physician], n=1). Conclusions: These data provide preliminary information on perampanel use during pregnancy. The data, however, cannot be used to estimate the prevalence of adverse pregnancy outcomes with perampanel exposure due to limited exposures, loss to follow-up, and selective reporting. Funding: Eisai Inc. Disclosure: Dr. Vazquez has received research support from Blanca Vazquez has received research support from Biogen MA Inc., Cavion LLC, Engage Therapeutics Inc., Ovid Therapeutics, Neurelis, SK Life Science Inc., UCB Biopharma SPRL, and UCB Biosciences, Inc... Dr. Tomson has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Speaker honorarium Eisai. Dr. Tomson has received research support from Eisai, UCB, Bial, GSK, Teva. Dr. Dobrinsky has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai. Dr. Schuck has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai. Dr. O’Brien has received research support from My institution received grant and other research support from Eisai, UCB, Zynerba and Praxis Medicine..