Ferric maltol Pregnancy and Breastfeeding Warnings

Brand names: Accrufer

Medically reviewed by Drugs.com. Last updated on Jun 29, 2022.

Ferric maltol Pregnancy Warnings

Use is considered acceptable.

US FDA pregnancy category: Not formally assigned to a pregnancy category

Risk summary: No data available on use of this drug in pregnant women to inform a drug related risk.

Comments:
-This drug is not systemically available as an intact compound.
-Animal studies of oral ferric or ferrous compounds administered during organogenesis at doses 13 to 32 times the recommended human dose showed no adverse developmental outcomes.
-An iron overdose during pregnancy carries a risk of spontaneous abortion, gestational diabetes, and fetal malformation.
-Untreated iron deficiency anemia during pregnancy is associated with adverse outcomes such as post-partum anemia , preterm delivery and low birth weight.

Animal studies of oral ferric or ferrous compounds administered daily during organogenesis at doses 13 to 32 times the recommended human dose showed no adverse developmental outcomes and no maternal toxicity. A multigeneration reproductive and developmental study of oral administration of this drug at doses 6 times the recommended human dose showed no maternal toxicity or adverse developmental outcomes. There are no controlled data in human pregnancy.

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.

See references

Ferric maltol Breastfeeding Warnings

Use if clinically needed

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-This drug is not systematically available, and so is unlikely to pass into human milk.
-No effects of oral ferric iron have been seen in newborns/infants of treated patients.

See references

Further information

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