Ferric carboxymaltose Pregnancy and Breastfeeding Warnings

Brand names: Injectafer

Medically reviewed by Drugs.com. Last updated on Sep 14, 2023.

Ferric carboxymaltose Pregnancy Warnings

Animal studies revealed evidence of embryotoxicity, increased malformations, and implantation loss at maternally toxic IV iron doses between 12% and 23% of the human weekly dose. There are no controlled data in human pregnancy. Published studies and postmarketing reports are insufficient to assess the risk of major defects and miscarriage.

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.
-Parenteral iron administration may cause hypersensitivity reactions that could lead to serious consequences such as fetal bradycardia. Advise pregnant women of the potential risk to the fetus.
-Some authorities suggest that if the benefit outweighs the risk, the IV treatment with this drug should be confined to women beyond 16 weeks of gestation. Iron deficiency in earlier pregnancy in many cases can be treated with oral iron.

See references

Ferric carboxymaltose Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes

Comments:
-Monitor breastfed infants for gastrointestinal adverse reactions (constipation, diarrhea).
-There is no information on the effects of this drug on milk production.
-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.

See references

Further information

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

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