Identifying Maternal Conditions Leading to Gabapentinoid Prescriptions in Pregnancy Using Electronic Health Records from Six European Countries: A Contribution from the IMI ConcePTION Project

Anna-Belle Beau (), Olga Paoletti, Justine Bénévent, Marie Beslay, Xavier Moisset, Elisa Ballardini, Laia Barrachina-Bonet, Clara Cavero-Carbonell, Alex Coldea, Laura García-Villodre, Anja Geldhof, Rosa Gini, Mika Gissler, Sue Jordan, Maarit K. Leinonen, Marco Manfrini, Visa Martikainen, Vera R. Mitter, Joan K. Morris, Amanda J. Neville, Hedvig Nordeng, Aurora Puccini, Jingping Mo and Christine Damase-Michel
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Anna-Belle Beau: Toulouse University
Olga Paoletti: Regional health agency of Tuscany
Justine Bénévent: Toulouse University
Marie Beslay: Toulouse University
Xavier Moisset: Université Clermont Auvergne
Elisa Ballardini: University Hospital of Ferrara, IMER Registry (Emilia Romagna Registry of Birth Defects), University of Ferrara
Laia Barrachina-Bonet: Rare Disease Research Unit, Foundation for Promotion of Health and Biomedical Research of Valencian Region (FISABIO)
Clara Cavero-Carbonell: Rare Disease Research Unit, Foundation for Promotion of Health and Biomedical Research of Valencian Region (FISABIO)
Alex Coldea: Swansea University
Laura García-Villodre: Rare Disease Research Unit, Foundation for Promotion of Health and Biomedical Research of Valencian Region (FISABIO)
Anja Geldhof: Janssen Biologics B.V.
Rosa Gini: Regional health agency of Tuscany
Mika Gissler: Finnish Institute for Health and Welfare
Sue Jordan: Swansea University
Maarit K. Leinonen: Finnish Institute for Health and Welfare
Marco Manfrini: Ferrara University
Visa Martikainen: Finnish Institute for Health and Welfare
Vera R. Mitter: Bern University of Applied Sciences
Joan K. Morris: City St George’s, University of London
Amanda J. Neville: University Hospital of Ferrara
Hedvig Nordeng: University of Oslo
Aurora Puccini: Emilia-Romagna Regional Center of Pharmacovigilance
Jingping Mo: Pfizer Inc.
Christine Damase-Michel: Toulouse University

Drug Safety, 2025, vol. 48, issue 11, No 2, 1189-1204

Abstract: Abstract Introduction and Objective Given the recent increase in the prescription and dispensation of gabapentinoids (gabapentin and pregabalin) and the importance of controlling for underlying maternal illnesses in drug safety studies, we aimed to develop algorithms for identifying maternal conditions leading to gabapentinoid prescribing among pregnant women using data from six electronic healthcare data sources across Europe. Methods The study was conducted in Finland, France (Haute-Garonne), Italy (Emilia Romagna), Norway, Spain (Valencian region), and Wales (UK), covering three million pregnancies from 2006 to 2020. Algorithms were developed to detect epilepsy, neuropathic pain, and generalized anxiety disorder (GAD) (approved indications for gabapentinoids by the European Medicines Agency, with the exception of gabapentin for GAD) using data ± 1 year around the gabapentinoid prescription date. Data included prescriber specialty, primary and specialized health care diagnoses, and co-prescription/dispensation data. Additional analyses investigated potential unlicensed indications (such as fibromyalgia, restless legs syndrome, bipolar disorder) and potential for abuse (using codes for substance use disorders and alcohol withdrawal). Results Gabapentinoids were prescribed/dispensed in 1770 pregnancies (7.7 per 1000) in Spain, 2912 pregnancies (6.6 per 1000) in Wales, 3163 pregnancies (3.6 per 1000) in Norway, 2406 pregnancies (3.0 per 1000) in Finland, 908 pregnancies (2.2 per 1000) in Italy, and 269 pregnancies (1.9 per 1000) in France. A maternal condition related to gabapentinoid prescriptions was identified by the algorithm in 2797 (88.4%) in Norway, 2180 (74.9%) in Wales, 1269 (71.7%) in Spain, 1534 (63.8%) in Finland, 163 (60.6%) in France, and 396 (43.6%) pregnancies in Italy. Anxiety (licensed or unlicensed) was the most commonly captured condition in Wales (70.5%), Spain (51.5%), Finland (42.0%), and Italy (26.2%), whereas neuropathic pain prevailed in Norway (76.9%) and France (49.8%). Epilepsy was the least frequent maternal condition leading to gabapentinoid prescriptions across all data sources (below 15% of all pregnancies). The relative preponderance of these conditions differed between pregabalin and gabapentin. Additionally, unlicensed indications were captured in 0% to 13% of pregnancies, depending on the data source. The analyses of potential for abuse showed that records of alcohol withdrawal and/or substance use disorders (within 1 year before and after the gabapentinoids prescription/dispensation date) were present in 3% of pregnancies in Italy and up to 23% in Wales. Conclusions Our study provides valuable insights into gabapentinoid use during pregnancy, with anxiety being the most common condition among pregnant women with gabapentinoid prescriptions in Finland, Italy, Spain, and Wales, whereas neuropathic pain predominated in France and Norway. Moreover, we found that between 3 and 23% of these pregnancies were associated with substance abuse, underscoring the need for careful prescribing of commonly abused medicines. The proposed methods for detecting maternal conditions leading to prescribing will facilitate accurate assessment of medication use and safety during pregnancy, whilst addressing confounding by indication.

Date: 2025
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DOI: 10.1007/s40264-025-01565-2

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