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USE OF LABETALOL IN PREGNANCY

Date of issue: May 2024, Version: 4

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

Labetalol is a non-selective beta-blocker with additional alpha adrenoceptor blocking properties. It is licensed for the treatment of mild to severe hypertension, hypertension in pregnancy, and angina pectoris with existing hypertension. NICE guidelines state that where clinically appropriate, labetalol is recommended as first-line antihypertensive treatment in pregnancy. 

Data relating to congenital malformation risk following gestational labetalol exposure are extremely limited. No studies have assessed the overall congenital malformation risk following labetalol exposure in pregnancy. Although single studies have found no association between gestational exposure to labetalol and congenital heart defects or hypospadias, these findings remain to be confirmed, and are likely confounded. It is noteworthy that while some women with chronic hypertension may be switched to labetalol during early pregnancy, gestational hypertension is, by definition, diagnosed after 20 gestational weeks and its treatment will therefore pose a low risk of structural anomaly.

Overall, the available studies do not suggest that gestational labetalol exposure increases the risks of fetal growth restriction or preterm delivery; however, because maternal hypertension is associated with both of these outcomes, analysis is complex. Limited data do not raise concern that gestational labetalol exposure increases the risk of stillbirth. Data on miscarriage and neurodevelopmental outcomes are too limited to permit a risk assessment.

Use of beta-blockers near term may result in beta-adrenoceptor blockade, leading to neonatal bradycardia, hypotension and hypoglycaemia. Although data are conflicting, with some studies not identifying increased risks, one large study which utilised advanced methods to control for confounding variables described 1.8- and 1.3-fold increased risks of neonatal hypoglycaemia and bradycardia, respectively, following maternal use of labetalol in pregnancy. Assessment of the neonate for these effects is therefore advised.

Exposure to labetalol at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy. In pregnancies complicated by maternal hypertension and/or where labetalol has been administered, careful monitoring of fetal growth is advised. 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 considering 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.