Sodium Ferric Gluconate Complex Interactions

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions (5.1) ] , which may have serious consequences, such as fetal bradycardia (see Clinical Considerations ) . Advise pregnant women of the potential risk to the fetus. Available data from postmarketing reports with Ferrlecit use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage. Ferrlecit contains benzyl alcohol as a preservative. Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. However, adverse reactions have occurred in premature neonates and low-birth-weight infants who received intravenously administered benzyl alcohol–containing drugs [see Warnings and Precautions (5.4) and Use in Specific Populations (8.4) ] . Consider alternative iron replacement therapies without benzyl alcohol. There are risks to the mother and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations ) . In the absence of maternal toxicity, Ferrlecit was not teratogenic to offspring of pregnant mice or rats at clinically relevant exposures (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Fetal/Neonatal adverse reactions Severe adverse reactions including circulatory failure (