ArticleJournal of neurology2025
Safety concerns of maternal antiseizure medications exposure on perinatal and offspring outcomes: a disproportionality analysis based on FDA adverse event reporting system.
Article in Journal of neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- Real-world evidence on gadoteridol safety: A 20-year FAERS database study revealing critical adverse reaction patterns.Medicine · 2026Article
- Lacosamide Safety During Pregnancy and Breastfeeding: A Single-Centre Experience and Comprehensive Narrative Review.Pharmacy (Basel, Switzerland) · 2026Article
- Late Pregnancy Antiseizure Medication Exposure and Offspring Neurodevelopmental Risk: A Multi-Child Cohort Study.Annals of neurology · 2026Article
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
backgroundMany women are exposed to antiseizure medications (ASMs) during pregnancy, raising concerns about pregnancy and offspring health risks. The current safety data remain insufficient, necessitating further investigation.
methodsUsing data from the FDA Adverse Event Reporting System (2010-2023), this study employed both the Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) for disproportionality analysis of pregnancy and offspring toxicity related to maternal ASM exposure. In addition, we performed signal adjustment by excluding polytherapy cases, and drug-drug interaction (DDI) signals of two ASMs were identified using Ω Shrinkage measures and Chi-square tests.
results3,459 mothers were exposed to 23 ASMs, resulting in 10,910 adverse events. 59 malformation signals, 27 adverse perinatal outcome signals, and 35 dysplasia signals were identified. Among traditional ASMs, valproic acid (VPA) and carbamazepine (CBZ) exhibited the highest number of signals, while levetiracetam (LEV), lamotrigine (LTG), lacosamide, gabapentin, and topiramate (TPM) predominated among newer ASMs. Signals for cardiac malformations, adverse neurodevelopment, and adverse offspring growth outcomes were widespread, with the strongest signals for specific outcomes observed for zonisamide [ROR = 14.82, 95% CI: 5.43-40.41], gabapentin [ROR = 52.52, 95% CI: 15.68-175.95], and brivaracetam [ROR = 22.96, 95% CI: 8.42-62.61], respectively. Six DDI signals displayed ≥ 3, including LTG + LEV/VPA associated with malformation, CBZ + lacosamide/LTG, and VPA + clonazepam associated with fetal loss.
conclusionsThe potential risks associated with LEV and LTG surpass expectations, warranting further evaluation, particularly in combination therapy. In addition, ASMs with widespread signals, such as VPA, CBZ, TPM, and lacosamide, warrant heightened attention.
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