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Iron dextran Pregnancy and Breastfeeding Warnings

Iron dextran is also known as: Dexferrum, Infed

Iron dextran Pregnancy Warnings

Teratogenic and embryocidal effects have occurred when iron dextran was given to laboratory animals at 3 times the maximum recommended human dose. Additionally, toxicity has been reported with doses ranging from 125 mg/kg of elemental iron as a single dose to a total intravenous dose of 90 mg/kg of elemental iron over a 14 day period. However, no consistent adverse fetal effects were observed at doses of 50 mg/kg of elemental iron or less. The animals used in these laboratory tests were not iron deficient. Small amounts of iron cross the placenta, however, the form in which it crosses is not known. Neonatal serum iron concentrations have increased when iron dextran was administered within 2 weeks of delivery. No adverse effects were reported.

Iron dextran has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryolethality and teratogenicity. There are no controlled data in human pregnancy. Iron dextran should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

See references

Iron dextran Breastfeeding Warnings

Zavaleta and colleagues found that oral iron sulfate given to anemic women after delivery did not effect milk iron or lactoferrin concentrations.

Traces of unmetabolized iron dextran are excreted into human milk. However, adverse effects in infants have not been reported. Iron dextran should be administered with caution during breast-feeding.

See references

References for pregnancy information

  1. Djaldetti M, Notti I, Fishman P, Bessler H "Transfer of iron-dextran across the placenta." Acta Haematol 53 (1975): 292-9
  2. Kaisi M, Ngwalle EW, Runyoro DE, Rogers J "Evaluation of tolerance of and response to iron dextran (Imferon) administered by total dose infusion to pregnant women with iron deficiency anemia." Int J Gynaecol Obstet 26 (1988): 235-43
  3. Stein ML, Gunston KD, May RM "Iron dextran in the treatment of iron-deficiency anaemia of pregnancy. Haematological response and incidence of side-effects." S Afr Med J 79 (1991): 195-6
  4. "Product Information. INFeD (iron dextran)." Schein Pharmaceuticals Inc, Florham Park, NJ.
  5. Manson IW "Total dose infusion with iron-dextran complex in pregnancy and the puerperium." Med J Aust 1 (1966): 174-7
  6. Fahmy K "Systemic reactions with total dose infusion of iron dextran complex in obstetric patients." Int J Gynaecol Obstet 16 (1978): 170-2
  7. Bingham D, Khalaf MM, Walters G, Whicher JT "Increased transfer of iron to the fetus after total dose infusion of iron dextran during pregnancy." J Clin Pathol 36 (1983): 907-9
  8. Pathak UN, Wood JK, Sorhaindo BA "Anemia of pregnancy treated with single intravenous dose of iron- dextran." Obstet Gynecol 29 (1967): 500-7

References for breastfeeding information

  1. "Product Information. INFeD (iron dextran)." Schein Pharmaceuticals Inc, Florham Park, NJ.
  2. Zavaleta N, Nombera J, Rojas R, Hambraeus L, Gislason J, Lonnerdal B "Iron and lactoferrin in milk of anemic mothers given iron supplements." Nutr Res 15 (1995): 681-90

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