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Edetate calcium disodium Pregnancy and Breastfeeding Warnings

Edetate calcium disodium is also known as: Calcium Disodium Versenate

Edetate calcium disodium Pregnancy Warnings

Edetate calcium disodium has been assigned to pregnancy category B by the FDA. One reproduction study was preformed in rats at doses up to 13 times the human dose and revealed no evidence of impaired fertility or harm to the fetus. Another study performed in rats at doses up to 25 to 40 times the human dose revealed evidence of fetal malformations due to edetate calcium disodium which were prevented by simultaneous supplementation of dietary zinc. The low molecular weight and the fact that 5% of the plasma concentration can be found in the spinal fluid indicate that edetate calcium disodium would cross the placental barrier. However, the very short elimination half-life will limit the amount of drug at the maternal-fetal interface. Because animal studies are not always predictive of human response, edetate calcium disodium should be used during pregnancy only if clearly needed.

Edetate calcium disodium Breastfeeding Warnings

The low molecular weight suggests that edetate calcium disodium will be excreted into breast milk, but the short half-life may limit the amount excreted. The risk to a nursing infant from exposure to edetate calcium disodium in milk is unknown but appears to be low or nonexistent. However, because the use of edetate calcium disodium implies poisoning with lead, this metal also will be excreted into milk and is toxic to a nursing infant. Therefore, breast-feeding is contraindicated in women receiving edetate calcium disodium.

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