USE OF NEBIVOLOL IN PREGNANCY

Nebivolol is a cardioselective beta blocker licensed for the treatment of hypertension and chronic heart failure.

The available data relating to nebivolol use in pregnancy are highly limited. There is a single case report of an infant, liveborn at term with a normal birth weight following exposure during the final four months of pregnancy to nebivolol. Additionally, two uneventful pregnancy outcomes associated with nebivolol exposure have been reported to UKTIS. A single, small study found no adverse effects on fetal growth following in utero exposure to nebivolol. Further research is required to confirm this finding, particularly given that beta blocker class data have suggested such effects. There are no further studies of rates of specific pregnancy outcomes following gestational exposure to nebivolol. An evidence-based assessment of the potential risks of congenital malformation, miscarriage, stillbirth, preterm delivery and adverse neurodevelopmental effects is therefore not possible.

Studies of beta blockers as a class do not show that use during pregnancy is associated with fetal structural malformation. Use of beta blockers in pregnancy has been associated with adverse effects on fetal growth; however maternal hypertension is linked to intrauterine growth restriction, therefore the relative 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 miscarriage, 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 advised. There is a single case report of a term infant exposed to nebivolol during the final four months of pregnancy with neonatal hypoglycaemia, jaundice, polycythaemia, mild thrombocytopenia and hyponatremia. Due to the nature of this report, causality cannot be ascribed to nebivolol exposure.

Exposure to nebivolol 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 hypertension and/or maternal cardiac disease, regardless of pharmacotherapy. Additional growth scans should be offered following gestational exposure to beta blockers. 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.

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