Beta-Blocker Use in Pregnancy and Risk of Specific Congenital Anomalies: A European Case-Malformed Control Study.

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Version: Final published version
Serval ID
serval:BIB_8367D2490EED
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Beta-Blocker Use in Pregnancy and Risk of Specific Congenital Anomalies: A European Case-Malformed Control Study.
Journal
Drug safety
Author(s)
Bergman JEH, Lutke L.R., Gans ROB, Addor M.C., Barisic I., Cavero-Carbonell C., Garne E., Gatt M., Klungsoyr K., Lelong N., Lynch C., Mokoroa O., Nelen V., Neville A.J., Pierini A., Randrianaivo H., Rissmann A., Tucker D., Wiesel A., Dolk H., Loane M., Bakker M.K.
ISSN
1179-1942 (Electronic)
ISSN-L
0114-5916
Publication state
Published
Issued date
04/2018
Peer-reviewed
Oui
Volume
41
Number
4
Pages
415-427
Language
english
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
The prevalence of chronic hypertension is increasing in pregnant women. Beta-blockers are among the most prevalent anti-hypertensive agents used in early pregnancy.
The objective of this study was to investigate whether first-trimester use of beta-blockers increases the risk of specific congenital anomalies in offspring.
A population-based case-malformed control study was conducted in 117,122 registrations of congenital anomalies from 17 European Concerted Action on Congenital Anomalies and Twins (EUROCAT) registries participating in EUROmediCAT with data for all or part of the period between 1995 and 2013. Associations previously reported in the literature (signals) were tested and an exploratory analysis was performed to identify new signals. Odds ratios of exposure to any beta-blocker or to a beta-blocker subgroup were calculated for each signal anomaly compared with two control groups (non-chromosomal, non-signal anomalies and chromosomal anomalies). The exploratory analyses were performed for each non-signal anomaly compared with all the other non-signal anomalies.
The signals from the literature (congenital heart defects, oral clefts, neural tube defects and hypospadias) were not confirmed. Our exploratory analysis revealed that multi-cystic renal dysplasia had significantly increased odds of occurring after maternal exposure to combined alpha- and beta-blockers (adjusted odds ratio 3.8; 95% confidence interval 1.3-11.0).
Beta-blocker use in the first trimester of pregnancy was not found to be associated with a higher risk of specific congenital anomalies in the offspring, but a new signal between alpha- and beta-blockers and multi-cystic renal dysplasia was found. Future large epidemiological studies are needed to confirm or refute our findings.
Keywords
Abnormalities, Drug-Induced/etiology, Adrenergic beta-Antagonists/adverse effects, Adult, Antihypertensive Agents/adverse effects, Case-Control Studies, Congenital Abnormalities/etiology, Female, Heart Defects, Congenital/chemically induced, Humans, Odds Ratio, Pregnancy, Pregnancy Complications/chemically induced, Pregnancy Trimester, First/drug effects, Prenatal Exposure Delayed Effects/chemically induced, Prevalence, Registries, Risk Factors, Young Adult
Pubmed
Web of science
Open Access
Yes
Create date
30/01/2018 10:29
Last modification date
20/08/2019 15:43
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