Outcomes in three cases after brivaracetam treatment during pregnancy

Abstract

Background Use of certain antiseizure drugs (ASDs) during pregnancy increases the risk of major congenital malformations, while less is known about newer ASDs. Based on the safety of levetiracetam, brivaracetam may be similarly safe in pregnancy; however, no cases have been published to date. Aims of the Study We retrospectively identified three women with epilepsy treated with brivaracetam during pregnancy and described the maternal and neonatal outcomes. Methods We reviewed the patients' medical records as well as the linked medical records of their infants to identify complications during pregnancy and delivery, neonatal complications, and evidence of major/minor congenital malformations. Results Our series included one woman with idiopathic generalized epilepsy and two women with focal epilepsy (brivaracetam doses ranging from 50 to 200 mg daily). One patient with focal epilepsy experienced breakthrough seizures, and lamotrigine was added to brivaracetam. The other women had no neurologic complications during pregnancy. All three women had full‐term deliveries without significant complications. Three healthy infants were born with Apgar scores of 9 and 9 and no major congenital malformations. Three minor congenital malformations were observed in two infants. Conclusions While the absence of major congenital malformations in these cases is encouraging, further data are needed to determine the safety of brivaracetam in pregnancy.

Treatment and care of women with epilepsy before, during, and after pregnancy: a practical guide

“… 48 – 50 There is no sign of teratogenicity in rat or rabbit models. 51 Until to date, only three reports of WWE treated with brivaracetam during pregnancy. 51 One woman had idiopathic generalized epilepsy (patient 1) and two had focal epilepsies (patient 2 and patient 3).…”

“… 51 Until to date, only three reports of WWE treated with brivaracetam during pregnancy. 51 One woman had idiopathic generalized epilepsy (patient 1) and two had focal epilepsies (patient 2 and patient 3). Brivaracetam doses ranged from 50 to 200 mg/day.…”

Structure-Activity Relationship (SAR) Model for Predicting Teratogenic Risk of Antiseizure Medications in Pregnancy by Using Support Vector Machine

“…In the FDA drug labeling, the evidence provided by animal studies showed that these three ASMs had developmental toxicity in pregnant rats or rabbits at clinically relevant doses or at plasma exposures greater than clinical exposures, including visceral abnormalities, skeletal abnormalities, decreased fetal weight and embryo-fetal death for perampanel exposure at dose of 1, 3 or 10 mg/kg/day, skeletal abnormalities, decreased fetal weight and embryo-fetal death for rufinamide exposure at dose of 20, 100, and 300 mg/kg/day, and embryo-fetal death and decreased fetal weight only for highest dose brivaracetam exposure. One case report reported 2 cases of minor congenital malformations in the offspring exposed to brivaracetam during pregnancy (Paolini et al, 2020). As a result, our model can be used as a tool to alert new drugs that still lack clinical evidence for teratogenicity.…”

Women’s Issues in Epilepsy

“…These anomalies included de novo unbalanced chromosomal 18, conjoined twins, congenital knee dislocation, talipes, and cytogenic abnormality with most deemed unlikely related to eslicarbazepine exposure 54 . Lacosamide has three published exposures in pregnancy and no major congenital malformations observed in offspring, 55 whereas brivaracetam has three published exposures (two on polypharmacy) with no observed major congenital malformation, although minor malformations were described, including congenital dermal melanocytosis, ankyloglossia (n = 1), and hemangioma on the thumb and back (n = 1) 56 . The available data on newer antiseizure medications are currently insufficient to draw conclusions.…”