Aarhus Universitets segl

English

Du er her: AU » Om AU » Organisation » Prenatal exposure to pregabalin, birth outcomes and neuro...

Om AU

Prenatal exposure to pregabalin, birth outcomes and neurodevelopment – a population-based cohort study in four Nordic countries

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

DOI

  • Elena Dudukina
    • ,
  • Szimonetta Komjáthiné Szépligeti
  • Pär Karlsson, Karolinska Institutet
    • ,
  • Kofi Asomaning, Pfizer
    • ,
  • Anne Kjersti Daltveit, University of Bergen, Norwegian Institute of Public Health
    • ,
  • Katja Hakkarainen, IQVIA Inc.
    • ,
  • Fabian Hoti, Spektri
    • ,
  • Helle Kieler, Karolinska Institutet
    • ,
  • Astrid Lunde, University of Bergen
    • ,
  • Ingvild Odsbu, Karolinska Institutet, Norwegian Institute of Public Health
    • ,
  • Matti Rantanen, Spektri
    • ,
  • Johan Reutfors, Karolinska Institutet
    • ,
  • Laura Saarelainen, Spektri
    • ,
  • Vera Ehrenstein
  • Gunnar Toft

Introduction: Pregabalin is an antiepileptic drug frequently prescribed to pregnant women. Risks of adverse birth and postnatal neurodevelopmental outcomes following prenatal exposure to pregabalin are uncertain. Objective: To investigate the association between prenatal exposure to pregabalin and the risks of adverse birth and postnatal neurodevelopmental outcomes. Methods: This study was conducted using population-based registries in Denmark, Finland, Norway, and Sweden (2005–2016). We compared pregabalin exposure against no exposure to antiepileptics and against active comparators lamotrigine and duloxetine. We obtained pooled propensity score-adjusted estimates of association using fixed-effect and Mantel–Haenszel (MH) meta-analyses. Results: The total number of pregabalin-exposed births was 325/666,139 (0.05%) in Denmark, 965/643,088 (0.15%) in Finland, 307/657,451 (0.05%) in Norway, and 1275/1,152,002 (0.11%) in Sweden. The adjusted prevalence ratios (aPRs) with 95% confidence interval (CI) following pregabalin exposure versus no exposure were 1.14 (0.98–1.34) for major congenital malformations and 1.72 (1.02–2.91) for stillbirth, which attenuated to 1.25 (0.74–2.11) in MH meta-analysis. For the remaining birth outcomes, the aPRs were close to or attenuated toward unity in analyses using active comparators. Adjusted hazard ratios (95% CI) contrasting prenatal pregabalin exposure versus no exposure were 1.29 (1.03–1.63) for ADHD and attenuated when using active comparators, 0.98 (0.67–1.42) for autism spectrum disorders, and 1.00 (0.78–1.29) for intellectual disability. Conclusions: Prenatal exposure to pregabalin was not associated with low birth weight, preterm birth, small for gestational age, low Apgar score, microcephaly, autism spectrum disorders, or intellectual disability. On the basis of the upper value of the 95% confidence interval, increased risks greater than 1.8 were unlikely for any major congenital malformation and ADHD. For stillbirth and most groups of specific major congenital malformations, the estimates attenuated in MH meta-analysis.

OriginalsprogEngelsk
TidsskriftDrug Safety
Vol/bind46
Nummer7
Sider (fra-til)661-675
Antal sider15
ISSN0114-5916
DOI
StatusUdgivet - jul. 2023

Se relationer på Aarhus Universitet Citationsformater

ID: 321686774