USE OF LEVETIRACETAM IN PREGNANCY

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(Date of issue: December 2019, Version: 3.1)

This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a pregnancy reporting form. Please encourage all women to complete an online reporting form.

A corresponding patient information leaflet on levetiracetam use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Levetiracetam is an anticonvulsant used either in monotherapy, or as adjunctive therapy for focal or partial onset seizures with or without secondary generalisation, myoclonic seizures in juvenile myoclonic epilepsy, and primary generalised tonic-clonic seizures.

Overall, congenital malformation rates have been studied in approximately 2,000 infants prenatally exposed during the first trimester to levetiracetam monotherapy, with no evidence of any increased risk, although in some cases study methodologies limit conclusions. There are also currently no identified associations between levetiracetam exposure and a small number of specific malformations. Although some studies have shown that use of levetiracetam in polytherapy may be linked to an increased risk of malformations compared to levetiracetam monotherapy, data are conflicting and, in some cases, potentially confounded by co-exposure to sodium valproate, an established teratogen. There is currently no evidence of a dose-effect.
 
Although generally reassuring, the data relating to miscarriage, stillbirth, premature delivery and infant birth weight are too limited to facilitate an accurate assessment of any potential risks posed by levetiracetam use in pregnancy and women should be made aware of the lack of data for these outcomes. Data regarding adverse neurodevelopmental outcomes following prenatal exposure to levetiracetam are reassuring, however, due to the small number of exposed children analysed, more research is required.

Use of any centrally-acting drug throughout pregnancy or near delivery may be associated with withdrawal symptoms in the neonate and/or poor neonatal adaptation syndrome (PNAS). These symptoms are likely to be more severe in infants exposed in utero to more than one CNS acting drug. Delivery should be planned in a unit with adequate neonatal facilities.

Levetiracetam is not known to impact maternal folate status. However, UK guidelines state that women who take any antiepileptic medication should be prescribed high dose folic acid (5mg).

Plasma concentrations of levetiracetam have been shown to decline as pregnancy progresses and regular clinical review of women taking levetiracetam is therefore recommended. Levetiracetam dose may need to be increased to maintain seizure control, particularly in the third trimester of pregnancy. Levetiracetam should only be used during pregnancy where the benefits of treatment are considered to outweigh any potential risks. Other risk factors may be also present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.

This document is regularly reviewed and updated. Only use full UKTIS monographs downloaded directly from TOXBASE.org to be sure you are using the most up-to-date version. The summaries of these monographs are openly available on UKTIS.org

This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to health care professionals at www.toxbase.org.

If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.

If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.

Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. The final decision regarding which treatment is used for an individual patient remains the clinical responsibility of the prescriber. This material may be freely reproduced for education and not for profit purposes within the UK National Health Service, however no linking to this website or reproduction by or for commercial organisations is permitted without the express written permission of this service. This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to ensure you are using the most up-to-date version.