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

Elena Dudukina (), Szimonetta Komjáthiné Szépligeti, Pär Karlsson, Kofi Asomaning, Anne Kjersti Daltveit, Katja Hakkarainen, Fabian Hoti, Helle Kieler, Astrid Lunde, Ingvild Odsbu, Matti Rantanen, Johan Reutfors, Laura Saarelainen, Vera Ehrenstein and Gunnar Toft
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Elena Dudukina: Aarhus University and Aarhus University Hospital
Szimonetta Komjáthiné Szépligeti: Aarhus University and Aarhus University Hospital
Pär Karlsson: Karolinska Institutet, Karolinska University Hospital
Kofi Asomaning: Pfizer Inc.
Anne Kjersti Daltveit: University of Bergen
Katja Hakkarainen: Real World Solutions, IQVIA
Fabian Hoti: Real World Solutions, IQVIA, Spektri
Helle Kieler: Karolinska Institutet, Karolinska University Hospital
Astrid Lunde: University of Bergen
Ingvild Odsbu: Karolinska Institutet, Karolinska University Hospital
Matti Rantanen: Real World Solutions, IQVIA, Spektri
Johan Reutfors: Karolinska Institutet, Karolinska University Hospital
Laura Saarelainen: Real World Solutions, IQVIA, Spektri
Vera Ehrenstein: Aarhus University and Aarhus University Hospital
Gunnar Toft: Steno Diabetes Center Aarhus

Drug Safety, 2023, vol. 46, issue 7, No 5, 675 pages

Abstract: Abstract 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.

Date: 2023
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DOI: 10.1007/s40264-023-01307-2

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