Digoxin Pregnancy Warnings
Animal studies have not been reported. In humans, adverse fetal effects have been reported at doses that produced maternal toxicity. There are no controlled data in human pregnancy.
AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
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.
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 recommended only if clearly needed and the benefit outweighs the risk.
AU TGA pregnancy category: A
US FDA pregnancy category: C (oral); Not assigned (injectable)
Risk Summary: No risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes has been identified.
Comments:
-If this drug is used during pregnancy, neonates should be monitored for signs and symptoms of toxicity (e.g., vomiting, cardiac arrhythmias).
-Dose requirements may increase during pregnancy and decrease in the postpartum period.
See references
Digoxin Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Yes (in small amounts)
Comments: This drug has been used without apparent harmful effects in the nursing infant.
This drug is excreted into breast milk in small amounts, and therefore, any amount ingested through breastfeeding would not be expected to cause adverse effects in the nursing infant. If the mother is scheduled to receive this drug intravenously, some experts recommend avoidance of breastfeeding for 2 hours after the dose to lessen the amount received by the infant.
See references
