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Pharmacoepidemiology

Gabapentin Use During Pregnancy and Adverse Neonatal Birth Outcomes: A Canadian multisite Population-Based Cohort Study Alekhya Lavu* Alekhya Lavu Payam Peymani Silvia Alessi-Severini Chelsea Ruth Jamison Falk Karina Kowalec Christine Leong Shelley Derksen Roxana Dragan Marcus C. Ng Brandace Winquist Joseph Delaney Sherif Eltonsy

Introduction

Gabapentin is a new-generation antiseizure medication approved for epilepsy. Due to gabapentin’s perceived safety in pregnancy and efficacy in reducing pain, there has been an increase in the off-label use of gabapentin. We aim to study the association between gabapentin treatment during pregnancy and adverse neonatal outcomes in two Canadian provinces.

Methods

We conducted a multi-site population-based retrospective cohort study of pregnant people in Manitoba from 1998 to 2021 and Saskatchewan from 1995-2023. We examined the association between gabapentin and the risk of small for gestational age (SGA), low birth weight (LBW), preterm birth, NICU admissions, infants’ length of hospital stays (LOS) (> 3 days), infant mortality (≤27), neonatal mortality (≤365 days), neonatal respiratory distress syndrome (NRDS), severe neonatal morbidity (SNM) and neonatal readmissions among all pregnant people. Multivariate regression models were adjusted for clinical covariates and confounders. We meta-analyzed aggregated data from both sites using random effects model.

 

Results

We included a total of 545,121 pregnancies in our analysis including 1663 pregnant people exposed to gabapentin. We observed a significant increase in the risk of SGA (adjusted odds ratio [aOR] 1.19,95%CI 1.06-1.33), preterm birth (aOR 1.62,95%CI 1.37-1.91), LOS infant (aOR 1.82,95%CI 1.40-2.36), infant mortality (aOR 1.48,95%CI 1.04-2.11), neonatal mortality (aOR 1.56,95%CI 1.04-2.34), neonatal readmissions (aOR 1.29,95%CI 1.02-1.64), SNM(aOR 1.22,95%CI 1.08-1.38) and a non-significant increased risk of LBW (aOR 1.19,95%CI 0.45-3.12), NICU admissions (aOR 1.57,95%CI 0.97-2.60), and  NRDS (aOR 1.85,95%CI 0.72-7.78) when compared with unexposed pregnant people.

Conclusion

Gabapentin exposure in pregnant people was associated with a significantly increased risk of several adverse birth outcomes in infants. Future studies must focus on gabapentin safety among epilepsy and non-epilepsy conditions.