Show simple item record

dc.contributor.authorDudukina, Elena
dc.contributor.authorSzépligeti, Szimonetta Komjáthiné
dc.contributor.authorKarlsson, Pär
dc.contributor.authorAsomaning, Kofi
dc.contributor.authorDaltveit, Anne Kjersti Nesje
dc.contributor.authorHakkarainen, Katja
dc.contributor.authorHoti, Fabian
dc.contributor.authorKieler, Helle
dc.contributor.authorLunde, Astrid
dc.contributor.authorOdsbu, Ingvild
dc.contributor.authorRantanen, Matti
dc.contributor.authorReutfors, Johan
dc.contributor.authorSaarelainen, Laura
dc.contributor.authorEhrenstein, Vera
dc.contributor.authorToft, Gunnar
dc.description.abstractIntroduction: 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.en_US
dc.rightsNavngivelse-Ikkekommersiell 4.0 Internasjonal*
dc.titlePrenatal exposure to pregabalin, birth outcomes and neurodevelopment - a population-based cohort study in four Nordic countriesen_US
dc.typeJournal articleen_US
dc.typePeer revieweden_US
dc.rights.holderCopyright 2023 the authorsen_US
dc.source.journalDrug Safetyen_US
dc.identifier.citationDrug Safety. 2023.en_US

Files in this item


This item appears in the following Collection(s)

Show simple item record

Navngivelse-Ikkekommersiell 4.0 Internasjonal
Except where otherwise noted, this item's license is described as Navngivelse-Ikkekommersiell 4.0 Internasjonal