Bisoprolol is a cardioselective beta-blocker 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.
A single small prospective cohort study found no increased risk of miscarriage or major congenital malformation following gestational bisoprolol exposure. An increased rate of preterm delivery and a small reduction in median birth weight (around 200 g) were identified. However, as these outcomes are also associated with maternal hypertension and cardiac disease, confounding is likely to be an issue. There are no further controlled studies assessing adverse pregnancy outcome following gestational exposure to bisoprolol. Case reports describe both adverse and uneventful outcomes, but the uncontrolled nature of these data limits any meaningful conclusion. Due to limited data, it is not possible to quantify the exact risk (if any) of adverse fetal outcome following bisoprolol use in pregnancy.
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 advised.
Exposure to bisoprolol at any stage in pregnancy would not be regarded as medical grounds for termination of pregnancy. Additional fetal monitoring is generally indicated in pregnancies complicated by maternal hypertension and maternal cardiac disease, regardless of pharmacotherapy. 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.