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Ferrous sulfate Pregnancy and Breastfeeding Warnings

Ferrous sulfate is also known as: Chem-Sol, Fe 50, Fe Caps, Feosol Original, Fer-Gen-Sol, Fer-In-Sol, Fer-Iron, Feratab, Fero-Gradumet Filmtab, FeroSul, Ferra T.D. Caps, Ferra-TD, Ferro-Bob, Ferro-Time, Ferrospace, Ferrousal, Iron Sulfate, Lydia E. Pinkham, Mol-Iron, MyKidz Iron 10, Slow Fe, Slow Release Iron, Yieronia

Ferrous sulfate Pregnancy Warnings

Ferrous sulfate has not been formally assigned to a pregnancy category by the FDA. There are no controlled data in human pregnancy. Human case reports have not revealed evidence of teratogenicity. Ferrous sulfate should be given during pregnancy only when the potential benefits outweigh the potential risks.

Generally, iron is considered safe for use during pregnancy and is regularly prescribed as a component of prenatal vitamin/mineral supplements. However, controversy exists as to whether or not routine iron supplementation is needed in the non-anemic pregnant patient. Anemia may be a risk factor for preterm delivery and low birth weight and should be diagnosed and treated as soon as possible, either before pregnancy or in the first trimester. Because supplementation with iron may reduce the dietary absorption of zinc, it may be important to assess zinc status as well. Most prenatal vitamins also contain adequate amounts of zinc. Absorption of iron and zinc may be reduced if calcium is also a component of the prenatal multivitamin.

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Ferrous sulfate Breastfeeding Warnings

One study demonstrated that a moderate iron supplementation of non-anemic nursing mothers (40 mg elemental iron daily over 3 months starting 2 days after delivery) resulted in increased maternal iron reserves, no significant alterations in milk iron concentration or lactoferrin, and no harmful effect on the infant. Another study evaluated oral iron supplementation in 19 anemic women receiving 100 mg elemental iron per day starting 2 days after delivery and continuing for 30 days. Ten non-anemic women had received iron supplementation during pregnancy. Iron and lactoferrin concentrations in milk obtained at 2 and 30 days after delivery did not differ between groups at either stage of lactation.

Several reports suggest that iron supplementation during lactation does not significantly affect the total concentration of iron in human milk. Ferrous sulfate administration during lactation is generally considered safe for the infant by most clinicians.

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References for pregnancy information

  1. "Routine iron supplementation during pregnancy. Policy statement: US Preventive Services Task Force." JAMA 270 (1993): 2846-8
  2. Peters PW, Garbis-Berkvens HM, Bannigan JG "Drugs of choice in pregnancy: primary prevention of birth defects." Reprod Toxicol 7 (1993): 399-404
  3. Guldholt IS, Trolle BG, Hvidman LE "Iron supplementation during pregnancy." Acta Obstet Gynecol Scand 70 (1991): 9-12
  4. Harju E "Clinical pharmacokinetics of iron preparations." Clin Pharmacokinet 17 (1989): 69-89
  5. Scholl TO, Hediger ML "Anemia and iron-deficiency anemia: compilation of data on pregnancy outcome." Am J Clin Nutr 59 (1994): s492-500dicuion500-5
  6. "Routine iron supplementation during pregnancy. Review article: US Preventive Services Task Force." JAMA 270 (1993): 2848-54

References for breastfeeding information

  1. 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
  2. Harju E "Clinical pharmacokinetics of iron preparations." Clin Pharmacokinet 17 (1989): 69-89
  3. Zapata CV, Donangelo CM, Trugo NMF "Effect of iron supplementation during lactation on human milk composition." J Nutr Biochem 5 (1994): 331-7

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