Auryxia Pregnancy Warnings
Benefit should outweigh risk
US FDA pregnancy category: Not assigned
Risk Summary: There are no data available on the use of this drug during pregnancy to inform a drug associated risk of major birth defects or miscarriage; an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation.
Comments:
-Requirements for vitamins and other nutrients increase in pregnancy; the effect of this drug on vitamin absorption and other nutrients has not been studied in pregnant women.
Animal studies have not been conducted with this drug. In neonatal mice, skeletal and encephalic malformation were observed following intraperitoneal administration of ferric gluconate to pregnant dams on gestation days 7 through 9. Oral administration of other ferric or ferrous compounds showed no fetal malformations. 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.
See references
Auryxia Breastfeeding Warnings
Studies on various forms of iron indicate that breastmilk levels are not greatly increased following exogenous iron administration. Rat studies have shown the transfer of iron into milk by divalent metal transporter-1 and ferroportin-1, so infant exposure is possible when this drug is administered to a nursing woman. The development and health benefits of breastfeeding should be considered
along with the mother's clinical need for therapy and any potential adverse effects on the breastfed child from this drug or from the underlying maternal condition.
Use is generally considered acceptable; benefit to mother should outweigh risk to the infant
Excreted into human milk: Data not available
Excreted into animal milk: Yes
Comments:
-There are no human data regarding the effect of this drug on human milk, the effects on the breastfed child, or the effects on milk production.
See references
