USE OF PROPRANOLOL IN PREGNANCY

Propranolol is a non-selective beta-blocker licensed for the treatment of hypertension, angina, migraine prophylaxis, hypertrophic cardiomyopathy, arrhythmias, management of essential tremor and anxiety, adjunctive management of thyrotoxicosis, and prophylaxis of upper gastro-intestinal bleeding in patients with portal hypertension and oesophageal varices.

The published data on use of propranolol in pregnancy are limited. A single case-control study found no association between propranolol exposure and cleft lip and/or palate, and two further case-control studies provide no evidence of an association with hypospadias. These data are limited both in scope and methodology, preventing conclusions being drawn about malformation risk. Data relating to risks of low infant birth weight and preterm delivery are limited and conflicting, and potentially confounded by the physiological effects of maternal hypertension and higher rates of early induction of delivery. There are no controlled studies that report rates of miscarriage, stillbirth, or adverse neurodevelopmental effects following gestational propranolol exposure.

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 malformation. Use in pregnancy has been associated with adverse effects on fetal growth, although as described above, maternal hypertension is linked to intrauterine growth restriction and analysis is therefore complex. Overall, data do not suggest that gestational beta-blocker exposure directly 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 thus advised.

Exposure to propranolol 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.