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Cisplatin Pregnancy and Breastfeeding Warnings

Cisplatin is also known as: Platinol, Platinol-AQ

Cisplatin Pregnancy Warnings

Cisplatin has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryotoxicity and teratogenicity in mice. There are no controlled data in human pregnancy. Cisplatin should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Out of five known cases where cisplatin was used during pregnancy, four resulted in normal healthy infants. In the fifth case, the mother had been treated with a combination of cisplatin, bleomycin, and etoposide. Both the mother (one week prior to delivery) and the infant (three days after birth) developed neutropenia. Ten days after birth, the infant began losing scalp hair and lanugo. Etoposide was felt to be the causative agent for the neutropenia and alopecia. In one study, cisplatin was administered to male rats before mating. Significant reductions were found in reproductive organ weights, sperm counts, sperm motility, fertility, and levels of testosterone.

Cisplatin Breastfeeding Warnings

One case report found milk platinum levels to be one-tenth plasma levels. Another case report found milk platinum levels to be essentially the same as maternal plasma levels. The majority of platinum found in the milk is probably bound to protein and is therefore essentially inactive. Based on the confirmed presence of platinum in breastmilk, however, fetal harm is possible and breast-feeding should be discontinued during cisplatin therapy.

Cisplatin is excreted into human milk. Breast-feeding is considered to be contraindicated by the manufacturer.

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