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

Elena Dudukina1, Szimonetta Komjáthiné Szépligeti2, Pär Karlsson3

  • 1Department of Clinical Epidemiology, Aarhus University and Aarhus University Hospital, Olof Palmes Allé 43-45, 8200, Aarhus N, Denmark. e.dudukina@clin.au.dk.

Drug Safety
|April 26, 2023
PubMed

Insights

Prenatal exposure to pregabalin was not linked to major birth defects or developmental issues. While a slight increase in stillbirth risk was observed, it attenuated in further analysis, suggesting no significant association.

Area of Science:

  • Obstetrics and Gynecology
  • Pharmacology
  • Developmental Pediatrics

Background:

  • Pregabalin is commonly prescribed to pregnant women for conditions like epilepsy.
  • The safety of prenatal pregabalin exposure regarding birth and neurodevelopmental outcomes requires further investigation.

Approach:

  • Utilized population-based registries from Denmark, Finland, Norway, and Sweden (2005-2016).
  • Compared pregabalin exposure against no antiepileptic drug use and against lamotrigine and duloxetine.
  • Employed propensity score-adjusted meta-analyses (fixed-effect and Mantel-Haenszel).

Key Points:

  • Prenatal pregabalin exposure showed no association with major congenital malformations, low birth weight, preterm birth, small for gestational age, low Apgar score, microcephaly, autism spectrum disorders, or intellectual disability.
  • An initial elevated risk for stillbirth was observed (aPR 1.72), but this attenuated in meta-analysis.
  • Adjusted hazard ratios for ADHD were elevated (1.29) but attenuated when using active comparators.

Conclusions:

  • Prenatal pregabalin exposure is not significantly associated with most adverse birth or postnatal neurodevelopmental outcomes.
  • Increased risks for major congenital malformations and ADHD greater than 1.8 were unlikely.
  • Findings suggest a generally favorable safety profile for pregabalin during pregnancy, though further research may be warranted for specific outcomes like stillbirth.
Abstract

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