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Ferric carboxymaltose Pregnancy and Breastfeeding Warnings

Ferric carboxymaltose is also known as: Injectafer

Medically reviewed on April 24, 2018

Ferric carboxymaltose Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity and increases in fetal skeletal abnormalities at maternally toxic IV iron doses. There are no controlled data in human pregnancy. Published studies have not reported adverse developmental outcomes with use of ferric carboxymaltose, however these studies were not designed to assess birth defect risk, and therefore cannot establish or exclude drug related pregnancy risks.

Iron deficiency that occurs in the first trimester of pregnancy can generally be treated with oral iron therapy. If the benefits of ferric carboxymaltose outweigh the potential risks, its use should be restricted to the second and third trimester.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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 only if the benefit outweighs the risk to the developing fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Comments:
-There are risks to mother and fetus from untreated iron deficiency during pregnancy, including preterm delivery, low birth weight and post-partum anemia.

See references

Ferric carboxymaltose Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes

Comments:
-Monitor breastfed infants for gastrointestinal toxicity (constipation, diarrhea).
-Consider the developmental and health benefits of breastfeeding and the mother's clinical need for this medication against any potential adverse effects on the child from the drug or from the underlying maternal condition.

The transfer of iron from ferric carboxymaltose was reported at 1% or lower. Among breastfed infants, no adverse events were considered related to this drug. There is no data on this drugs effects on milk production.

In a study of 25 lactating women with postpartum iron deficiency anemia, the mean breast milk iron levels were higher in lactating women receiving ferric carboxymaltose injection than in lactating women receiving oral ferrous sulfate.

Out of the 229 women breastfeeding their infants in a study of postpartum mothers given intravenous ferric carboxymaltose, 24 infants had an adverse effect reported. The most frequent reactions were reported to include erythema, constipation, diarrhea, and nasopharyngitis.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Injectafer (ferric carboxymaltose)." American Regent Laboratories Inc, Shirley, NY.
  4. US Food and Drug Administration "Drug Safety Labeling Changes (SLC). Injectafer. Available from: URL: https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1435" ([2018, Jan 26]):

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Injectafer (ferric carboxymaltose)." American Regent Laboratories Inc, Shirley, NY.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. US Food and Drug Administration "Drug Safety Labeling Changes (SLC). Injectafer. Available from: URL: https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1435" ([2018, Jan 26]):

Further information

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

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