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Julie Werenberg Dreier

Prenatal exposure to valproate and risk of congenital malformations-Could we have known earlier?-A population-based cohort study

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Prenatal exposure to valproate and risk of congenital malformations-Could we have known earlier?-A population-based cohort study. / Christensen, Jakob; Trabjerg, Betina B; Sun, Yuelian; Gilhus, Nils Erik; Bjørk, Marte-Helene; Tomson, Torbjörn; Dreier, Julie Werenberg.

I: Epilepsia, Bind 62, Nr. 12, 12.2021, s. 2981-2993.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

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@article{b3553c1611b44620bcc29036c8782444,
title = "Prenatal exposure to valproate and risk of congenital malformations-Could we have known earlier?-A population-based cohort study",
abstract = "OBJECTIVE: Prenatal exposure to the antiseizure medication (ASM) valproate is associated with an increased risk of congenital malformations, but warnings against the use of valproate in pregnancy were not issued until 2009. The objective was to study how early administrative health registers could have identified the teratogenic risk associated with valproate.METHODS: This was a population-based cohort study of individual-linked data from Danish health care and socioeconomic registers including children born in Denmark between January 1, 1997 and December 31, 2014. Information on ASM use, including valproate, in pregnancy was obtained from the Danish National Prescription Registry. Children identified with major congenital malformations from the Danish National Patient Register and the Danish Register of Causes of Death were included. Using logistic regression models, we estimated odds ratios (ORs) and 95% confidence intervals (CIs) for major congenital malformations during the first year of life in children with and without prenatal exposure to ASMs adjusted for potential confounders.RESULTS: Among the 895 507 children (males, 51.3%), 31 790 (3.6%) were diagnosed with a major congenital malformation in the first year of life. In the analyses including children born in 1997, the risk of major congenital malformations among children prenatally exposed to valproate compared with children not exposed to ASMs was increased by a fully adjusted OR (aOR) of 3.95 (95% CI = 1.65-9.47). With the addition of data from the following years, the teratogenic effect of valproate was further substantiated, as the precision of the estimate improved (1997-2014: aOR = 2.44, 95% CI = 1.80-3.30).SIGNIFICANCE: Using Danish health care data, we were able to identify a teratogenic risk associated with prenatal valproate exposure in children born in 1997, which is much earlier than prospective clinical cohorts. Health registry data represent an important tool for early identification of risk associated with drugs in pregnancy.",
keywords = "adverse events, antiseizure medication, congenital malformations, pregnancy, women, SAFETY, DISORDERS, PREVALENCE, PREGNANCY, UNCLASSIFIABLE EPILEPSY, WOMEN, SANAD, ANTICONVULSANT DRUGS, ANTIEPILEPTIC DRUGS, REGISTRY",
author = "Jakob Christensen and Trabjerg, {Betina B} and Yuelian Sun and Gilhus, {Nils Erik} and Marte-Helene Bj{\o}rk and Torbj{\"o}rn Tomson and Dreier, {Julie Werenberg}",
note = "{\textcopyright} 2021 International League Against Epilepsy.",
year = "2021",
month = dec,
doi = "10.1111/epi.17085",
language = "English",
volume = "62",
pages = "2981--2993",
journal = "Epilepsia",
issn = "0013-9580",
publisher = "Wiley-Blackwell Publishing, Inc.",
number = "12",

}

RIS

TY - JOUR

T1 - Prenatal exposure to valproate and risk of congenital malformations-Could we have known earlier?-A population-based cohort study

AU - Christensen, Jakob

AU - Trabjerg, Betina B

AU - Sun, Yuelian

AU - Gilhus, Nils Erik

AU - Bjørk, Marte-Helene

AU - Tomson, Torbjörn

AU - Dreier, Julie Werenberg

N1 - © 2021 International League Against Epilepsy.

PY - 2021/12

Y1 - 2021/12

N2 - OBJECTIVE: Prenatal exposure to the antiseizure medication (ASM) valproate is associated with an increased risk of congenital malformations, but warnings against the use of valproate in pregnancy were not issued until 2009. The objective was to study how early administrative health registers could have identified the teratogenic risk associated with valproate.METHODS: This was a population-based cohort study of individual-linked data from Danish health care and socioeconomic registers including children born in Denmark between January 1, 1997 and December 31, 2014. Information on ASM use, including valproate, in pregnancy was obtained from the Danish National Prescription Registry. Children identified with major congenital malformations from the Danish National Patient Register and the Danish Register of Causes of Death were included. Using logistic regression models, we estimated odds ratios (ORs) and 95% confidence intervals (CIs) for major congenital malformations during the first year of life in children with and without prenatal exposure to ASMs adjusted for potential confounders.RESULTS: Among the 895 507 children (males, 51.3%), 31 790 (3.6%) were diagnosed with a major congenital malformation in the first year of life. In the analyses including children born in 1997, the risk of major congenital malformations among children prenatally exposed to valproate compared with children not exposed to ASMs was increased by a fully adjusted OR (aOR) of 3.95 (95% CI = 1.65-9.47). With the addition of data from the following years, the teratogenic effect of valproate was further substantiated, as the precision of the estimate improved (1997-2014: aOR = 2.44, 95% CI = 1.80-3.30).SIGNIFICANCE: Using Danish health care data, we were able to identify a teratogenic risk associated with prenatal valproate exposure in children born in 1997, which is much earlier than prospective clinical cohorts. Health registry data represent an important tool for early identification of risk associated with drugs in pregnancy.

AB - OBJECTIVE: Prenatal exposure to the antiseizure medication (ASM) valproate is associated with an increased risk of congenital malformations, but warnings against the use of valproate in pregnancy were not issued until 2009. The objective was to study how early administrative health registers could have identified the teratogenic risk associated with valproate.METHODS: This was a population-based cohort study of individual-linked data from Danish health care and socioeconomic registers including children born in Denmark between January 1, 1997 and December 31, 2014. Information on ASM use, including valproate, in pregnancy was obtained from the Danish National Prescription Registry. Children identified with major congenital malformations from the Danish National Patient Register and the Danish Register of Causes of Death were included. Using logistic regression models, we estimated odds ratios (ORs) and 95% confidence intervals (CIs) for major congenital malformations during the first year of life in children with and without prenatal exposure to ASMs adjusted for potential confounders.RESULTS: Among the 895 507 children (males, 51.3%), 31 790 (3.6%) were diagnosed with a major congenital malformation in the first year of life. In the analyses including children born in 1997, the risk of major congenital malformations among children prenatally exposed to valproate compared with children not exposed to ASMs was increased by a fully adjusted OR (aOR) of 3.95 (95% CI = 1.65-9.47). With the addition of data from the following years, the teratogenic effect of valproate was further substantiated, as the precision of the estimate improved (1997-2014: aOR = 2.44, 95% CI = 1.80-3.30).SIGNIFICANCE: Using Danish health care data, we were able to identify a teratogenic risk associated with prenatal valproate exposure in children born in 1997, which is much earlier than prospective clinical cohorts. Health registry data represent an important tool for early identification of risk associated with drugs in pregnancy.

KW - adverse events

KW - antiseizure medication

KW - congenital malformations

KW - pregnancy

KW - women

KW - SAFETY

KW - DISORDERS

KW - PREVALENCE

KW - PREGNANCY

KW - UNCLASSIFIABLE EPILEPSY

KW - WOMEN

KW - SANAD

KW - ANTICONVULSANT DRUGS

KW - ANTIEPILEPTIC DRUGS

KW - REGISTRY

U2 - 10.1111/epi.17085

DO - 10.1111/epi.17085

M3 - Journal article

C2 - 34585373

VL - 62

SP - 2981

EP - 2993

JO - Epilepsia

JF - Epilepsia

SN - 0013-9580

IS - 12

ER -