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Nebivolol Pregnancy and Breastfeeding Warnings

Nebivolol is also known as: Bystolic

Medically reviewed on February 23, 2018

Nebivolol Pregnancy Warnings

Use is not recommended unless clearly needed.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk Summary: Use of beta blockers during the third trimester may increase the risk of neonatal hypotension, bradycardia, hypoglycemia, and respiratory depression.

Comments:
-If used during pregnancy, monitor placental blood flow and fetal growth
-After birth, monitor for the signs and symptoms of beta blockade, generally present in the first 3 days.

Animal studies at dose levels associated with maternal toxicity have revealed small delays in sternal and thoracic ossification and reductions in litter size and weight [at 18 times the maximum recommended human dose (MRHD)]. Furthermore, use in late gestation and parturition increased gestation, fetal death and stillbirths, and decreased weight, litter size, and survival (at doses of 1.2 times the MRHD). Beta-adrenergic blocking agents have been shown to decrease placental perfusion which has been associated with growth retardation, premature and immature deliveries and fetal death. Due to limited data, if a beta-blocking agent is required, may consider another beta-1-adrenoreceptor blocker. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected to causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Nebivolol Breastfeeding Warnings

Use not recommended

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: Breastfed infants should be monitored for the signs and symptoms of beta blockade, for example, bradycardia, respiratory distress, and hypoglycemia.

Beta-adrenergic blocking agents, particularly lipophilic agents like this drug, have caused adverse events in breastfed newborns. In animal models, this drug is excreted into breastmilk and is expected to have moderate accumulation in the infant due to its high protein binding and long half-life.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Bystolic (nebivolol)." Forest Pharmaceuticals, St. Louis, MO.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  4. "Product Information. Bystolic (nebivolol)." Forest Pharmaceuticals, St. Louis, MO.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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