Carvedilol is a non-cardioselective beta blocker licensed for the treatment of hypertension, angina pectoris, and symptomatic chronic heart failure (CHF).
Available data regarding carvedilol exposure in pregnancy is highly limited. There is a single case report of a non-malformed infant, born at term with a normal birth weight following exposure throughout pregnancy to carvedilol. A single, very small study found no adverse effects on fetal growth following in utero exposure to carvedilol and reported similar crude rates of preterm delivery for exposed and unexposed infants. Further research is required to confirm these findings, particularly given that beta blocker class data have suggested possible adverse effects on fetal growth. There are no further studies of rates of specific pregnancy outcomes following gestational exposure to carvedilol. An evidence-based assessment of the absolute risks of congenital malformation, miscarriage, stillbirth, preterm delivery, low infant birth weight 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, although because maternal hypertension is linked to intrauterine growth restriction, 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.
Exposure to carvedilol 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 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.
Related document: Use of beta blockers in pregnancy
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.