First-Trimester Antiepileptic Drug Exposure and Adverse Pregnancy Outcomes: Insights from a Cohort Study in the US
Author(s)
Nour Al Zaza, MSc, Gregoire Nowacki, MSc, Martina Furegato, MSc, Stefano Tagliabue, MSc, Nivantha Subiron-Naidoo, MPH, MSc, MD, Asma Hamid, MD, MPH.
Oracle, Paris, France.
Oracle, Paris, France.
OBJECTIVES: The increasing prevalence of antiepileptic drug (AED) use among women, particularly those of childbearing age, highlights the need for safety studies to assess the impact on pregnancy and fetal outcomes. Using a large and representative closed-claims database in the United States (US), this study aimed to evaluate the association between first trimester (T1) AED exposure and adverse pregnancy outcomes: preterm birth (PTB), spontaneous abortion (SA), and stillbirth (SB).
METHODS: Data from the Oracle US Claims database were analyzed retrospectively. We identified pregnancy episodes among women aged 15-49 years between July 2022 and July 2023. Pregnancy outcomes and trimesters were identified using diagnosis and procedure code algorithms. Exposure to any AED during T1 was assessed using prescription reimbursement codes. 1:1 propensity score-matching was applied to adjust for confounding. Adjusted odds ratios (ORs) for the association between AED exposure and pregnancy outcomes were assessed. A multinomial logistic regression model was used to account for exposure to teratogens drugs during pregnancy (as listed in the Teratogen Information System [TERIS] database), gestational diabetes, pregnancy-associated hypertension, Obstetric Comorbidity Index (OCI) and ethnicity.
RESULTS: Of 526,947 pregnancy episodes identified, 13,735 (2.6%) were AED-exposed and 513,212 were not AED-exposed during T1. In AED-exposed pregnancies, proportions of PTB, SB, and SA were 4.16% (N=700), 0.71% (N=120), and 20.65% (N=3,472) respectively. Proportions in non-AED exposed pregnancies were 3.79% (N=22,272) PTB, 0.64% (N=3,775) SB, and 12.33% (N=72,453) SA. T1 AED exposure was associated with increased odds of PTB (adjusted OR: 1.172, 95% CI: 1.078-1.274), SB (adjusted OR: 1.33, 95% CI: 1.104-1.603), and SA (adjusted OR: 2.993, 95% CI: 2.855-3.138).
CONCLUSIONS: This research revealed increased odds of adverse pregnancy outcomes associated with AED exposure. These findings highlight the need to further examine how these risks differ across various AED generations and treatment indications.
METHODS: Data from the Oracle US Claims database were analyzed retrospectively. We identified pregnancy episodes among women aged 15-49 years between July 2022 and July 2023. Pregnancy outcomes and trimesters were identified using diagnosis and procedure code algorithms. Exposure to any AED during T1 was assessed using prescription reimbursement codes. 1:1 propensity score-matching was applied to adjust for confounding. Adjusted odds ratios (ORs) for the association between AED exposure and pregnancy outcomes were assessed. A multinomial logistic regression model was used to account for exposure to teratogens drugs during pregnancy (as listed in the Teratogen Information System [TERIS] database), gestational diabetes, pregnancy-associated hypertension, Obstetric Comorbidity Index (OCI) and ethnicity.
RESULTS: Of 526,947 pregnancy episodes identified, 13,735 (2.6%) were AED-exposed and 513,212 were not AED-exposed during T1. In AED-exposed pregnancies, proportions of PTB, SB, and SA were 4.16% (N=700), 0.71% (N=120), and 20.65% (N=3,472) respectively. Proportions in non-AED exposed pregnancies were 3.79% (N=22,272) PTB, 0.64% (N=3,775) SB, and 12.33% (N=72,453) SA. T1 AED exposure was associated with increased odds of PTB (adjusted OR: 1.172, 95% CI: 1.078-1.274), SB (adjusted OR: 1.33, 95% CI: 1.104-1.603), and SA (adjusted OR: 2.993, 95% CI: 2.855-3.138).
CONCLUSIONS: This research revealed increased odds of adverse pregnancy outcomes associated with AED exposure. These findings highlight the need to further examine how these risks differ across various AED generations and treatment indications.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
EPH122
Topic
Epidemiology & Public Health
Topic Subcategory
Public Health, Safety & Pharmacoepidemiology
Disease
SDC: Mental Health (including addition), SDC: Reproductive & Sexual Health