Animal studies have failed to reveal evidence of teratogenicity. Reduced pup weights and increased postimplantation loss have been noted in rats and rabbits, respectively. In humans, hemorrhagic events and neonatal hemorrhage have occurred, but major congenital anomalies in live births occurred at rates similar to background rates. There have been postmarketing reports of fetal death, but causality has not been determined. There are no controlled data in human pregnancy.

Consideration for use of a shorter acting anticoagulant should be addressed as delivery approaches.

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 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.

This drug should be used during pregnancy only if clearly needed.

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

Risk Summary: Human data from a retrospective cohort study suggest that this drug does not increase the risk of major developmental abnormality.

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus and the mother. Preservative-free formulations are recommended if used during pregnancy.
-Pregnant women with thromboembolic disease, including those with mechanical prosthetic heart valves and those with inherited or acquired thrombophilia, have an increased risk of maternal complications and fetal loss.

See references

Due to its relatively large molecular weight, this drug is not expected to undergo excretion into breast milk or to be absorbed from breast milk by the infant.

Breastfeeding is not recommended during use of this drug and benefit should outweigh risk. However, use is generally considered acceptable per some authorities.

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

Comments: This drug has been used without apparent harmful effects in the nursing infant.

See references