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USE OF VIGABATRIN IN PREGNANCY

Date of issue: May 2024, Version: 3

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A corresponding patient information leaflet on USE OF VIGABATRIN IN PREGNANCY is available.

Vigabatrin is an anticonvulsant used predominantly in combination with other antiepileptic drugs (AEDs) in the treatment of resistant partial seizures, with or without secondary generalisation, where all other potential drug combinations have proved ineffective, are contraindicated, or not tolerated.

There is very limited information on the use of vigabatrin in pregnancy. Fetal toxicity and congenital malformation have been reported in animal studies. An initial report by the manufacturer of high rates of congenital malformation among children exposed in utero is likely to be heavily biased by concomitant maternal medication use and retrospective reporting.

The limited available data, derived from isolated case reports, small uncontrolled case series, cohort studies and a network meta-analysis do not currently provide evidence which reliably demonstrates that vigabatrin use in pregnancy increases the risk of congenital malformation, miscarriage, intrauterine fetal death, preterm delivery, or intrauterine growth restriction. However, given the available data is highly limited, it is not possible to exclude the risk of such effects and further studies are therefore required.

 Vigabatrin therapy in the non-pregnant patient has been associated with retinal and optic atrophy, peripheral field loss and electroretinogram abnormalities. It is unknown whether in utero exposure is also associated with visual disturbance in the offspring and until further data are available the possibility of an effect on fetal visual development cannot be ruled out. 

 Vigabatrin may impact upon maternal folate status. UK guidelines state that women who take any anti-epileptic medication should be prescribed high dose folic acid (5mg), although it is currently not known whether high dose folic acid supplementation offers any additional benefit or protective effects over standard dose regimes when taking vigabatrin preconceptually or during pregnancy.

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 neonatal intensive care facilities.

 More research is required to define the pregnancy safety profile of vigabatrin. Pregnant women and women of childbearing potential should be made aware of the lack of data for all pregnancy outcomes. Vigabatrin should only be used during pregnancy where benefits of treatment are considered to outweigh any potential risks. In view of the limited human pregnancy data, close monitoring of mother and fetus should be considered with use of vigabatrin in pregnancy. Other risk factors may also be 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 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 NHS health care professionals who are logged in.

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 UKTIS.org to ensure you are using the most up-to-date version.