(247) Adverse Fetal Outcomes Associated with Gabapentin Use in Pregnancy: A Population-Based Cohort Study and Meta-Analysis

Friday, August 26, 2022

8:00 AM – 6:00 PM CEST

Location: Hall C

Publication Number: 578

Presenting Author(s)

Brianne Desrochers
– The University of Manitoba

Co-Author(s)

Alekhya Lavu
– The University of Manitoba, University of Manitoba, Winnipeg, Manitoba, Canada
Eunice Valencia
– College of Pharmacy, Rady Faculty of Health Sciences University of Manitoba, Winnipeg, Canada., Canada
Christine Vaccaro, BSc
– College of Pharmacy, University of Manitoba, Winnipeg, MB, Canada
Sherif Eltonsy, PhD
– Assistant Professor, University of Manitoba, University of Manitoba, Winnipeg, Manitoba, Canada

Background: With the current increase in the use of gabapentin since the past decade, it’s important to better understand its neonatal safety considering its prevalent use among pregnant people.

Objectives: The objective of this study is to investigate the fetal safety of gabapentin during pregnancy using a cohort study and meta-analysis.

Methods: The current study includes a cohort study and a scoping review with meta-analysis. We conducted a population-based cohort study using the Manitoba Centre for Health Policy database between 1995 and 2019. Pregnancies exposed to gabapentin were compared to unexposed pregnancies. We examined the association between maternal gabapentin use and the prevalence of all congenital malformations, major congenital malformations (MCMs), cardiac and orofacial malformations, and neonatal intensive care unit (NICU) admissions. Generalized estimating equations models were used. Chromosomal abnormalities, multiple gestation, and stillbirths were excluded. We further conducted a literature search in MEDLINE and EMBASE databases from inception to locate relevant observational studies and conducted a meta-analysis using random effects models that included our cohort study results.

Results: Out of 289,227 included pregnancies, a total of 870 women were exposed to gabapentin. Exposure to gabapentin in first trimester was associated with a non-significant increased risk of any malformations (aOR 1.17 [95% CI 0.91-1.50]), MCMs (aOR 1.00 [95% CI 0.72-1.38]), cardiac malformations (aOR 1.29 [95% CI 0.72-2.31]) and orofacial malformations (aOR 1.37 [95% CI 0.50-3.77]). Exposure to gabapentin in all/any trimester was associated with a statistically significant increased risk of NICU admissions (aOR 2.18 [95% CI 1.81-2.62]). In the scoping review, A total of 1,351 citations were identified. The meta-analysis showed an increased risk of any malformations (OR 1.27 [95% CI 0.68-2.38, I2 40%]), MCMs (OR 1.51 [95% CI 1.21-1.89, I2 26%]), cardiac malformations (OR 1.59 [95% CI 1.22-2.08, I2 34%]), orofacial malformations (OR 0.63 [95% CI 0.09-4.49, I2 0%]) and NICU admissions (OR 3.74 [95% CI 3.33-4.19, I2 10%]).

Conclusions: In this study, gabapentin use showed a significant increased risk of NICU admissions, both in the cohort study and the pooled meta-analysis of 3 studies. Meta-analysis of 5 studies showed a significant increase in MCMs, and meta-analysis of 3 studies showed a significant increase in the risk of cardiac malformations with gabapentin use. Additional studies are needed to decide on the potential association between gabapentin use and any and orofacial malformations. The results suggest that clinicians must prescribe gabapentin with caution during pregnancy.