((B-263)) (B-263) Review of Pregnancy and Lactation Use Information for Antiepileptic Medications

Monday, August 25, 2025

11:30 AM - 1:00 PM ET

Location: Hall D

Presenting Author(s)

MA

Manal Alrohaimi

Drug Safety and Risk Management department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia., Saudi Arabia

Co-Author(s)

NA

Nouf Al-Fadel

Drug Safety and Risk Management department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia., Saudi Arabia
FA

Fawaz Alharbi

Saudi Food and Drug Authority, Saudi Arabia

Background:

Background: antiepileptic medications are associated with an increased risk of pregnancy complications, congenital malformations, developmental delays, and other adverse fetal outcomes. Therefore, their use during pregnancy and lactation requires careful assessment of benefit-risk balance.

Objectives:

Objective: To review pregnancy and lactation use information for antiepileptic medications in their pharmacovigilance regulatory document such as Periodic Benefit Risk Evaluation Report (PBRER) and Risk Management Plan (RMP).

Methods:

Methods: a comprehensive list of all registered antiepileptic medications was identified. Then, we assessed the current information related to the exposure of antiepileptic medications during pregnancy and lactation in their PBRERs/RMPs. Medications were categorized into three groups: (1) Medications with additional risk minimization measures (RMMs) specifically addressing antiepileptic medications’ risks related to pregnancy and lactation, (2) Medications where pregnancy and lactation use information is addressed in their PBRERs/RMPs, or (3) Medications where the risk of exposure during pregnancy and lactation was not mentioned at all.

Results:

Results: A total of 17 antiepileptic medications were identified. We exclude those contraindicated during pregnancy (N=3). Among the remaining 14 medications, only one medication has additional RMMs addressing the risk of major congenital malformations. A total of 9 medications had pregnancy and lactation information listed as either missing information or potential risk in their PBRERs/RMPs, with no plans mentioned to address this knowledge gap. Four medications did not discuss the risk of pregnancy and lactation exposure in their PBRERs/RMPs.

Conclusions:

Conclusion:
The findings highlight a gap in RMMs for antiepileptic medications used during pregnancy and lactation. While some medications acknowledge potential risks, the lack of structured plans to address knowledge gaps poses a concern for patient safety. Strengthening regulatory requirements and ensuring comprehensive safety assessments are crucial to optimizing the benefit-risk balance for pregnant and lactating women using antiepileptic medications.