Edoxaban Pregnancy and Breastfeeding Warnings
Brand names: Savaysa
Medically reviewed by Drugs.com. Last updated on Jul 31, 2023.
Edoxaban Pregnancy Warnings
Use is contraindicated per some authorities.
US FDA pregnancy category: Not assigned.
Risk Summary: Insufficient data exist to determine whether there are drug-associated risks for adverse developmental outcomes.
Animal studies revealed embryofetal toxicity at maternotoxic doses. There are no controlled data in human pregnancy.
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.
Edoxaban Breastfeeding Warnings
Use is not recommended, and per some authorities is contraindicated.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments: The effects in the nursing infant are unknown.
See also
References for pregnancy information
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- (2015) "Product Information. Savaysa (edoxaban)." Daiichi Sankyo, Inc.
References for breastfeeding information
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- (2015) "Product Information. Savaysa (edoxaban)." Daiichi Sankyo, Inc.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.