There are no adequate and well-controlled trials of iron(III) in pregnant women. A careful risk/benefit evaluation is therefore required before use during pregnancy and iron(III) should not be used during pregnancy unless clearly necessary.
Iron deficiency anaemia occurring in the first trimester of pregnancy can in many cases be treated with oral iron. Treatment with iron(III) should be confined to second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus. In rare cases, foetal bradycardia has been observed in pregnant women with hypersensitivity reactions.
A clinical study showed that transfer of iron from iron(III) to human milk was very low. At therapeutic doses of iron(III) no effects on the breastfeed newborns/infants are anticipated.
There are no data on the effect of iron(III) on human fertility. Fertility was unaffected following iron(III) treatment in animal studies.
No studies on the effects on the ability to drive and use machines have been performed.
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