Ferrous fumarate/folic acid/iron polysaccharide Pregnancy and Breastfeeding Warnings

Brand names: Tandem F

Ferrous fumarate/folic acid/iron polysaccharide Pregnancy Warnings

Ferrous fumarate and iron polysaccharide have not been formally assigned to a pregnancy category by the FDA. Folic acid has been assigned to pregnancy category A by the FDA when used in doses that are advocated by the FDA. Higher doses of folic acid have been assigned to pregnancy category C. There are no controlled data in human pregnancy. Human case reports have not revealed evidence of teratogenicity. Ferrous fumarate-folic acid-iron polysaccharide should be given during pregnancy only when the potential benefits outweigh the potential risks. Because of increased plasma clearance of folate during pregnancy, folic acid requirements are increased. Folic acid therapy or adequate dietary folic acid BEFORE conception may significantly decrease the risk of neural tube defects among pregnancies in women, even those with previously affected children. The manufacturer recommends women who are pregnant seek the advise of a health professional prior to taking ferrous fumarate-folic acid-iron polysaccharide and that appropriate diagnostic exclusion of Addisonian pernicious anemia (due to faulty/blocked absorption of vitamin B12 or extrinsic factors) should be carried out.

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Ferrous fumarate/folic acid/iron polysaccharide Breastfeeding Warnings

Several reports suggest that iron supplementation during lactation does not significantly affect the total concentration of iron in human milk. Folic acid is actively excreted into human milk. No adverse effects in nursing infants have been associated with the use of folic acid during lactation. Ferrous fumarate and iron polysaccharide administration during lactation is generally considered safe for the infant by most clinicians. Folic acid is considered compatible with breast-feeding by the American Academy of Pediatrics. The recommended maternal daily allowance of folic acid during lactation is 500 mcg. Supplementation is not typically needed in mothers with good nutritional habits. The manufacturer recommends women who are breast-feeding seek the advise of a health professional prior to taking ferrous fumarate-folic acid-iron polysaccharide.

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Further information

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