USE OF PREGABALIN IN PREGNANCY

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(Date of issue: September 2020, Version: 4)

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 pregabalin use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Pregabalin is an anticonvulsant used as adjunctive therapy in adults with partial seizures, with or without secondary generalisation, and in the treatment of neuropathic pain and generalised anxiety disorder.

Available data relating to fetal and pregnancy outcomes following gestational pregabalin use are provided by six controlled studies, which together describe the outcomes of more than 3,000 exposed pregnancies. Generally, data are provided from studies that included patients with chronic pain or other non-epilepsy indications. Although the number of exposed pregnancies is quite large, data regarding non-malformation outcomes remains limited.

The available data do not currently indicate that maternal pregabalin use in pregnancy is associated with increased risks of malformation or miscarriage, or adversely affects fetal growth.

A single study has described a possible association with preterm delivery, particularly following exposure in the second and/or third trimester. However, an impact of the underlying conditions for which pregabalin was prescribed could not be excluded due to methodological limitations. Further studies are therefore required to confirm or refute these findings.

No studies investigating the incidence of intrauterine death or neurodevelopmental impairment following maternal pregabalin use in pregnancy have been identified in the literature.

Although no controlled studies have assessed the risk of neonatal complication following prenatal pregabalin exposure, one study has described a small number of affected infants, including one case of neonatal withdrawal. Use of any centrally acting drug throughout pregnancy or near delivery may potentially 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 to more than one central nervous system (CNS)-acting drug. For all pregnancies with exposure to CNS-acting medication, delivery should be planned in a unit with adequate neonatal facilities.

Pregabalin is not known to impact maternal folate status. However, guidelines in the UK state that women who take any anti-epileptic medication should be prescribed high dose folic acid (5mg). Women should be made aware that it is not known whether high dose folic acid supplementation offers any benefit or protective effects over standard dose regimes when taking pregabalin preconceptually or during pregnancy. 

Exposure to pregabalin at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. However, other risk factors may 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 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.