Apixaban Pregnancy Warnings
Animal studies have failed to reveal evidence of adverse developmental effects. There are no controlled data in human pregnancy.
Use of this drug during labor or delivery in women receiving neuraxial anesthesia may result in epidural or spinal hematomas.
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.
Use is not recommended.
AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.
Risk Summary: Insufficient data exists to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental outcomes.
Comments:
-Treatment can cause uterine bleeding, that may require gynecological surgical intervention.
-Treatment can cause placental hemorrhage and subsequent fetal loss.
-This drug may increase the risk of bleeding in the fetus and neonate.
-Females of reproductive potential that require anticoagulation should discuss pregnancy planning options with their healthcare provider.
See references
Apixaban Breastfeeding Warnings
Animal studies in lactation did not result in death of offspring. The drug was excreted in the milk of the animal model at a high milk to plasma ratio, possibly due to active transport.
A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
The effects in the nursing infant are unknown.
See references
