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

Jorieke E. H. Bergman (), L. Renée Lutke, Rijk O. B. Gans, Marie-Claude Addor, Ingeborg Barisic, Clara Cavero-Carbonell, Ester Garne, Miriam Gatt, Kari Klungsoyr, Nathalie Lelong, Catherine Lynch, Olatz Mokoroa, Vera Nelen, Amanda J. Neville, Anna Pierini, Hanitra Randrianaivo, Anke Rissmann, David Tucker, Awi Wiesel, Helen Dolk, Maria Loane and Marian K. Bakker
Additional contact information
Jorieke E. H. Bergman: University of Groningen, University Medical Centre Groningen
L. Renée Lutke: University of Groningen, University Medical Centre Groningen
Rijk O. B. Gans: University of Groningen, University Medical Centre Groningen
Marie-Claude Addor: CHUV
Ingeborg Barisic: Medical School University of Zagreb
Clara Cavero-Carbonell: Foundation for the Promotion of Health and Biomedical Research of the Valencian Region, Rare Diseases Research Unit
Ester Garne: Hospital Lillebaelt
Miriam Gatt: Directorate for Health Information and Research
Kari Klungsoyr: The Norwegian Institute of Public Health
Nathalie Lelong: INSERM, UMR 1153
Catherine Lynch: Health Service Executive South East
Olatz Mokoroa: BioDonostia Health Research Institute
Vera Nelen: PIH
Amanda J. Neville: University of Ferrara
Anna Pierini: CNR Institute of Clinical Physiology/RTDC Registry (Tuscany Registry of Congenital Defects), Fondazione Toscana “Gabriele Monasterio”
Hanitra Randrianaivo: Registre des Malformations Congenitales de la Reunion
Anke Rissmann: Otto-von-Guericke University
David Tucker: Congenital Anomaly Register & Information Service for Wales, Public Health Wales
Awi Wiesel: University Medical Centre of Johannes Gutenberg University
Helen Dolk: Ulster University
Maria Loane: Ulster University
Marian K. Bakker: University of Groningen, University Medical Centre Groningen

Drug Safety, 2018, vol. 41, issue 4, No 9, 415-427

Abstract: Abstract Introduction The prevalence of chronic hypertension is increasing in pregnant women. Beta-blockers are among the most prevalent anti-hypertensive agents used in early pregnancy. Objective The objective of this study was to investigate whether first-trimester use of beta-blockers increases the risk of specific congenital anomalies in offspring. Methods 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. Results 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). Conclusion 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.

Date: 2018
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DOI: 10.1007/s40264-017-0627-x

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