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USE OF BISOPROLOL IN PREGNANCY

Date of issue: March 2010 Version: 1

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. To date, use of bisoprolol during pregnancy has not been associated conclusively with an increased risk of structural fetal malformations. Some recent studies have suggested a possible increased risk of congenital heart defects associated with antihypertensive therapy including beta-adrenoceptor blocking drugs, however it is unclear whether any risk is due to the underlying maternal condition or the medications. The use of beta-adrenoceptor blocking drugs in the first and second trimesters of pregnancy has been associated with intrauterine growth retardation (IUGR) and low birth weight. Use of a beta-adrenoceptor blocking drug near term may result in neonatal bradycardia, hypotension and hypoglycaemia. Respiratory distress and apnoea have also been reported. These effects may be attenuated by discontinuing treatment 24-48 hours before delivery, although data are conflicting. When reported, neonatal symptoms are usually mild and resolve within 48 hours. Treatment with bisoprolol would not be regarded as medical grounds for termination or any invasive diagnostic tests. Methyldopa is generally regarded as an appropriate first choice drug for treating hypertension in pregnancy when drug treatment is necessary. If methyldopa is not considered suitable then the beta-adrenoceptor blocking drugs labetalol and propranolol may be considered, however they are not without risk.
If you are pregnant and require advice regarding exposure to bisoprolol please contact your health care professional who can contact UKTIS on your behalf. If you have a patient with exposure to bisoprolol and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0844 892 0909 to discuss the case with a teratology specialist. If you would like to report a pregnancy where exposure to bisoprolol has occurred, please click here to download our pregnancy reporting form.

Disclaimer: Every effort has been made to ensure that this monograph is accurate and up-to-date. However it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. There is a background incidence of congenital malformations (2-3%) and spontaneous abortions (10-20%) irrespective of any drug or chemical exposure. 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.

UKTIS 2011