Esmolol Pregnancy and Breastfeeding Warnings
Brand names: Brevibloc
Medically reviewed by Drugs.com. Last updated on Dec 12, 2023.
Esmolol Pregnancy Warnings
This drug has caused increased fetal resorptions with minimal maternal toxicity in animal studies when given at doses approximately 8 times the maximum human maintenance dose. There are no adequate and well-controlled studies in pregnant women; however, use in the last trimester of pregnancy or during labor or delivery has been reported to cause fetal bradycardia, which continued after termination of the infusion.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
This drug should be used during pregnancy only if the benefit outweighs the risk.
AU TGA pregnancy category: C
US FDA pregnancy category: C
Comment:
-Beta blockers may cause decreased placental perfusion, fetal and neonatal bradycardia, and hypoglycemia.
Esmolol Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comment:
-The effects in the nursing infant are unknown.
Based on its physicochemical properties and extremely short half-life, this drug would not be expected to cause any adverse effects in breastfed infants; however, if this drug is used by a nursing mother, the infant should be carefully observed for signs of beta-blockade.
See also
References for pregnancy information
- Product Information. Brevibloc (esmolol). DuPont Pharmaceuticals. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
References for breastfeeding information
- Product Information. Brevibloc (esmolol). DuPont Pharmaceuticals. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
