Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Pregnancy
There are no adequate and controlled studies on the use of Ferrlecit in pregnant women. A careful risk-benefit assessment is therefore required before use during pregnancy, and Ferrlecit should not be used during pregnancy unless clearly necessary (see section 4.4).

Iron deficiency anaemia occurring in the first trimester of pregnancy can in many cases be treated with orally administered iron preparations. Treatment with Ferrlecit should be limited to the second and third trimesters if the benefit of the therapy is assessed to be greater than the potential risk to the mother and foetus.
Animal experimental studies have shown reproduction toxicity (see section 5.3). The potential risk to humans is not known.

Foetal bradycardia may occur after parenteral iron administration. This is usually temporary and occurs as a result of a hypersensitivity reaction of the mother.

Because of the rare circulatory reaction that can be caused by iron injection, there is a potential risk in pregnant women (see section 4.8) that, due to insufficient blood flow to the placenta, nutrition disorders may occur in the unborn child. Special attention must therefore be paid to correct use (see section 4.2).

Breast-feeding
It is not known whether increased excretion of iron into breast milk takes place after parenteral administration of iron. Ferrlecit should therefore only be used during breast-feeding after a careful risk-benefit assessment.

Fertility
There are no studies on the effect of Ferrlecit on fertility.