Vadadustat Pregnancy and Breastfeeding Warnings

Brand names: Vafseo

Medically reviewed by Drugs.com. Last updated on Apr 22, 2025.

Vadadustat Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

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

Risk summary: Inconclusive data available on use of this drug in pregnant women to inform a drug-related risk of major birth defects, miscarriage, or adverse fetal or maternal outcomes.

Comments:
-This drug and/or its metabolites were shown to cross the placenta in animal studies, and the potential for adverse effects on a developing fetus cannot be excluded.
-There are risks to the mother and the fetus associated with chronic kidney disease (CKD), including maternal hypertension, preeclampsia, miscarriage, stillbirth, preterm delivery, low birth weight and polyhydramnios.

Animal studies have revealed evidence of decreased fetal weight and fetal skeletal ossification when this drug was administered to pregnant rats or rabbits at doses up to 1.7 times the maximum recommended human dose. The reported developmental effects were associated with maternal toxicity defined by a decline in body weight and food consumption. 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 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.

See references

Vadadustat Breastfeeding Warnings

This drug should not be used during breastfeeding, and for 2 days after the final dose, due to the potential serious adverse effects on the infant.

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

Comments:
-There are no data available on the presence of this drug in human milk, its effects on the breastfed child, or on milk production.
-This drug and/or its metabolites are excreted in animal milk with peak concentrations in milk more than double that in plasma, and high overall exposure.
-A decision should be made to discontinue breastfeeding or to discontinue treatment, considering the benefits of breastfeeding for the child vs. the benefit of therapy for the woman.

See references

Further information

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

Medical Disclaimer