A review of the evidence on the risk of congenital malformations and neurodevelopmental disorders in association with antiseizure medications during pregnancy.
Details
Serval ID
serval:BIB_AFE84A1A5F2D
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
A review of the evidence on the risk of congenital malformations and neurodevelopmental disorders in association with antiseizure medications during pregnancy.
Journal
Expert opinion on drug safety
ISSN
1744-764X (Electronic)
ISSN-L
1474-0338
Publication state
Published
Issued date
12/2021
Peer-reviewed
Oui
Volume
20
Number
12
Pages
1487-1499
Language
english
Notes
Publication types: Comparative Study ; Journal Article ; Review
Publication Status: ppublish
Publication Status: ppublish
Abstract
Introduction: The majority of women with epilepsy require treatment with antiseizure medications (ASM) throughout pregnancy. However, in utero exposure to several ASM has been associated with an increased risk of congenital malformations and/or neurodevelopmental disorders (CM/NDD) in the child, but observational evidence is methodologically heterogeneous.Areas covered: We critically evaluate current evidence on the risk of CM/NDD in children of women with epilepsy after in utero exposure to different ASM. We highlight characteristics of different data sources and discuss their benefits and drawbacks. This review includes evidence published before December 2020.Expert opinion: Given the lack of randomized controlled trials, evidence on in utero safety of ASM originates from methodologically heterogeneous post-marketing observational studies based on registries, prospective cohorts, and large electronic health databases. It has been clearly demonstrated that valproate is associated with a high risk of CM/NDD, whereas lamotrigine and levetiracetam are relatively safe. However, evidence is less explicit for other ASM. Reported risks vary depending on the size and origin of the underlying study population, the definition of exposure and outcomes, and other aspects of the study design. Increased collaboration between data sources to increase sample size is desirable.
Keywords
Abnormalities, Drug-Induced/epidemiology, Abnormalities, Drug-Induced/etiology, Anticonvulsants/administration & dosage, Anticonvulsants/adverse effects, Child, Epilepsy/drug therapy, Female, Humans, Neurodevelopmental Disorders/chemically induced, Neurodevelopmental Disorders/epidemiology, Pregnancy, Pregnancy Complications/drug therapy, Prenatal Exposure Delayed Effects/epidemiology, Randomized Controlled Trials as Topic, Antiseizure medications, congenital malformations, drug safety, epilepsy, neurodevelopmental disorders, observational studies, pharmacoepidemiology, pregnancy, teratogenicity
Pubmed
Web of science
Create date
28/06/2021 10:58
Last modification date
26/02/2022 6:35