(260) A systematic review of gabapentinoids use during pregnancy and effects on pregnancy and childhood outcomes: an IMI ConcePTION study

Background: In the general population, there has been a noticeable rise in the dispensing of gabapentinoids (pregabalin and gabapentin) in recent years. Despite the increased use of gabapentinoids during pregnancy, there are limited publications and conflicting findings regarding their effects on the fetus and/or child.

Objectives: To provide a comprehensive overview of all existing data pertaining to the utilization and safety of gabapentinoids during pregnancy.

Methods: A systematic review was performed in PubMed and Reprotox and included all studies in English that reported on the use and safety of gabapentin and pregabalin during pregnancy. All original randomized clinical trials and observational studies (cohort, case-control, registry studies) were eligible. We excluded abstracts, literature reviews, case reports and studies involving fewer than 5 exposures. Two authors independently screened the studies, extracted the data and assessed the quality of the studies. Descriptive analyses and narrative syntheses were performed.

Results: A total of 24 high-quality studies were described. The prevalence of gabapentinoid use during pregnancy remained very low, at less than 1%. Two studies reported an increased risk of overall congenital anomalies and of certain specific anomalies (nervous system, eyes, oro-facial clefts, and genital system), stillbirth and specific neurodevelopmental outcomes after exposure to pregabalin during pregnancy. Concerning exposure to gabapentin, increased risks of preterm birth, preeclampsia, small-for-gestational-age and NICU admission were reported in one study.

Conclusions: The increase in the risks reported after exposure to pregabalin in pregnancy warrants further investigations. Cumulative data on the risk of spontaneous abortion, preterm birth and long-term effects on the health of offspring are sparse. The study highlights the importance of further research to inform clinical decisions and to ensure the safety of both pregnant women and their offspring.