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Ferrous gluconate Pregnancy and Breastfeeding Warnings

Ferrous gluconate is also known as: FE-40, Ferate, Fergon, Ferralet, Iron Gluconate, Simron

Medically reviewed on Sep 26, 2017

Ferrous gluconate Pregnancy Warnings

Maternal anemia increases the risk of low birthweight, premature delivery, and impaired cognitive and behavioral development. Randomized trials show that supplementation can prevent iron deficiency anemia and related adverse consequences to the infant. Recent studies have linked high serum iron with an increased risk of gestational diabetes.

AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

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.

Use is considered acceptable.

AU TGA pregnancy category: Exempt
US FDA pregnancy category: Not assigned

Comments:
-Routine screening for anemia, including in asymptomatic patients, is generally recommended.
-Routine supplementation during pregnancy is recommended by many organizations.

See references

Ferrous gluconate Breastfeeding Warnings

Use is considered acceptable.

Excreted into human milk: Yes


Comments:
-Iron in breast milk is very bioavailable, but amounts are generally not sufficient for infants older than 4 months; iron supplementation of the mother does not change this situation.
-Iron content of breast milk is not affected by the mother's nutritional status.

See references

References for pregnancy information

  1. McDonagh M, Cantor A, Bougatsos C, et al. "Routine Iron Supplementation and Screening for Iron Deficiency Anemia in Pregnant Women: A Systematic Review to Update the U.S. Preventive Services Task Force Recommendation [Internet] Available from: URL: https://www.ncbi.nlm.nih.gov/books/NBK285987/" ([2015, Mar]):
  2. Rawal S, Hinkle SN, Bao W, et.al "A longitudinal study of iron status during pregnancy and the risk of gestational diabetes: findings from a prospective, multiracial cohort." Diabetologia 60 (2017): 249-57
  3. Bao W, Chavarro JE, Tobias DK, et.al "Long-term risk of type 2 diabetes in relation to habitual iron intake in women with a history of gestational diabetes: a prospective cohort study." Am J Clin Nutr 103 (2016): 375-81
  4. World Health Organization (WHO) "Iron Deficiency Anaemia. Assessment, Prevention, and Control, A guide for programme managers Available from: URL: http://www.who.int/nutrition/publications/en/ida_assessment_prevention_control.pdf." ([2001]):
  5. Scholl TO, Reilly T "Anemia, Iron and Pregnancy Outcome." J Nutr 130 (2000): 443S-7S
  6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  7. NIH Office of Dietary Supplements "Iron Dietary Supplement Fact Sheet. Available from: URL: https://ods.od.nih.gov/factsheets/Iron-HealthProfessional/?print=1" ([2016, Feb 01]):

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Allen LH "Multiple micronutrients in pregnancy and lactation: an overview." Am J Clin Nutr 81(S) (2005): 1206S-12S
  3. Picciano MF "Pregnancy and Lactation: Physiological Adjustments, Nutritional Requirements and the Role of Dietary Supplements." J Nutr 133 (2003): 1997S-2002S
  4. NIH Office of Dietary Supplements "Iron Dietary Supplement Fact Sheet. Available from: URL: https://ods.od.nih.gov/factsheets/Iron-HealthProfessional/?print=1" ([2016, Feb 01]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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