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USE OF BISOPROLOL IN PREGNANCY

Date of issue: March 2016
Version: 2

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.

Summary

Bisoprolol is a cardioselective (beta1 selective) beta-adrenoceptor blocking drug licensed for the treatment of hypertension, angina pectoris and as adjunctive therapy in the treatment of stable chronic heart failure with reduced left ventricular function.

There are no studies of rates of specific pregnancy outcomes following gestational exposure to bisoprolol. An evidence-based assessment of the potential risks of congenital malformation spontaneous abortion, stillbirth, intrauterine growth restriction (IUGR), preterm delivery, and adverse neurodevelopmental effects following in utero exposure is therefore not possible and women should be made aware of this lack of data.
 
Studies of beta-blockers as a class have not, to date, provided conclusive evidence that use during pregnancy is associated with an increased risk of fetal structural malformations. Although some studies have suggested a possible increased risk of congenital heart defects, this has also been observed with other antihypertensive therapies and may therefore be non-drug-specific or linked to the underlying maternal condition. A meta-analysis has suggested that gestational beta-blocker exposure may be linked to increased risks of cleft lip and/or palate and neural tube defects in the infant, although these findings remain to be confirmed.

Use of beta-blockers in pregnancy has been associated with adverse effects on fetal growth, although because maternal hypertension is linked to intrauterine growth restriction, analysis is complex and any contribution of beta-blocker exposure to this outcome remains unquantified. Overall, data do not suggest that gestational beta-blocker exposure increases the risk of preterm delivery. Data on rates of spontaneous abortion, stillbirth and neurodevelopmental outcomes are too limited to permit a risk assessment.

Use of beta-blockers near term may result in neonatal beta-adrenoceptor blockade leading to neonatal bradycardia, hypotension and hypoglycaemia. Respiratory distress has also been reported. Assessment of the neonate for these effects is thus advised.

Exposure to bisoprolol 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.