Ferrous sulfate Pregnancy Warnings
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.
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.
See references
Ferrous sulfate 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