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Ferric citrate Pregnancy and Breastfeeding Warnings

Ferric citrate is also known as: Auryxia

Ferric citrate Pregnancy Warnings

Safety has not been established during pregnancy. US FDA pregnancy category: Not assigned Comments: -The effect of this drug on absorption of vitamins and other nutrients has not been studied in pregnant women. -Requirements for vitamins and other nutrients increase in pregnancy.

Animal studies have not been conducted with this drug. Animal studies of ferric gluconate showed skeletal and encephalic malformation when administered intraperitoneally to the dams on gestation days 7 to 9, however oral administration of other ferric or ferrous compounds caused no fetal malformations. There are no controlled data in human pregnancy. An overdose of iron in pregnant women carries a risk of spontaneous abortion, gestational diabetes, and fetal malformation. 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

Ferric citrate Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation. Excreted into human milk: Data not available Excreted into animal milk: Yes Comments: -There is a possibility of infant exposure when administered to a breastfeeding woman. -Consider the development and health benefits of breastfeeding along with the mother's need for this drug and any potential adverse effects on the child from this drug or from the mother's underlying condition.

See references

References for pregnancy information

  1. "Product Information. Auryxia (ferric citrate)." Keryx Biopharmaceuticals, Inc., New York, NY.

References for breastfeeding information

  1. "Product Information. Auryxia (ferric citrate)." Keryx Biopharmaceuticals, Inc., New York, NY.

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