Research and analysis

Public Assessment Report of antiepileptic drugs: review of safety of use during pregnancy

The Commission on Human Medicines has reviewed the available safety data for epilepsy medicines during pregnancy.

Documents

Antiepileptic drugs: review of safety of use during pregnancy

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Table 1: Prevalence rate of Congenital Malformations for prioritised AEDs

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Table 2a: Effects on IQ/Cognitive Effects

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Table 2b: Effects on Developmental Quotient (DQ)

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Table 2c: Autistic spectrum disorders (ASD) and Attention Deficit Hyperactivity Disorder (ADHD)

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Table 2d: Other Neurodevelopmental Effects

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Table 3a: Fetal Loss

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Table 3b Preterm Birth

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Table 3c: Prenatal Growth Restriction

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Details

The Commission on Human Medicines has reviewed the available safety data for epilepsy medicines during pregnancy. This review was initiated in the context of the known harms of valproate in pregnancy.

The overarching findings of the review are that lamotrigine (brand name Lamictal) and levetiracetam (brand name Keppra) are the safer of the reviewed antiepileptic drugs during pregnancy because they are not linked with an increased risk of birth abnormalities compared with the general population. The available information also does not suggest an increased risk of the child having difficulties with learning or thinking ability but further data are needed to draw firm conclusions. Doctors or specialist epilepsy nurses should use this information when discussing treatment options with women and girls with epilepsy when starting treatment and at routine recommended annual review, and with women who are planning a pregnancy.

Updates to this page

Published 7 January 2021

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