Highlights
- •Pregnant women are increasingly exposed to newer antiseizure medication like lacosamide although their safety has not been evidenced yet.
- •Preliminary data indicate no increased risk for spontaneous abortion or major birth defects related to lacosamide during pregnancy.
- •Effects of newer antiseizure medication on pregnancy outcome are difficult to specify, because of limited numbers of well documented pregnancies, frequent antiseizure co-medication and a high rate of terminated pregnancies.
Abstract
Introduction
Epilepsy is a common neurological disease requiring long-term therapy also during
pregnancy. Most studies on pregnancy outcomes in women with epilepsy are based on
antiseizure medication (ASM) in monotherapy. However, about 20-30% of epilepsy patients
require polytherapy and newer ASMs are an option, when seizure control is not achieved
with first line ASMs.
Methods
Observational study evaluating the use of newer ASMs with marketing authorization
since 2005 reported to the Embryotox Center of Clinical Teratology and Drug Safety
in Pregnancy between 2004 and 2019. In addition, course and outcome of lacosamide
exposed pregnancies were analysed.
Results
Our study confirms the increasing use of newer ASMs also in pregnant women. This is
especially true for lacosamide, eslicarbazepine and brivaracetam with rising numbers
of exposed pregnancies soon after marketing authorization. Analysis of 55 prospectively
and 10 retrospectively ascertained lacosamide exposed pregnancies does not indicate
increased risks of major birth defects or spontaneous abortion. However, bradycardia
observed in 3 neonates might be related to prenatal lacosamide exposure.
Conclusion
Available data do not support the assumption of lacosamide being a major teratogen.
The increasing use of newer ASMs during pregnancy underscores the need for more studies
to guide preconception counselling, especially for lacosamide, eslicarbazepine and
brivaracetam.
Keywords
Abbreviations:
ASM (antiseizure medication), BMI (body mass index), CI (confidence interval), EUROCAT (European network of population-based registries for the epidemiological surveillance of congenital anomalies), ETOP (elective termination of pregnancy), GW (gestational week), IQR (interquartile range), SAB (spontaneous abortion), SDS (standard deviation score), STROBE (Strengthening of the Reporting of Observational studies in Epidemiology)To read this article in full you will need to make a payment
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Article info
Publication history
Accepted:
February 16,
2023
Received in revised form:
February 14,
2023
Received:
January 9,
2023
Publication stage
In Press Journal Pre-ProofFootnotes
This work was performed with financial support from the German Federal Institute for Drugs and Medical Devices (BfArM) and German Research Foundation (DFG). The sponsor had no involvement in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.
The results of this study are part of the thesis of Sofia Slimi and parts of the results have been presented at the 30th annual meeting of the European Teratology information services (ENTIS) 2019
Identification
Copyright
© 2023 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.
