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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.

See references

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.

See references

References for pregnancy information

  1. "Product Information. Platinol (cisplatin)." Bristol-Myers Squibb, Princeton, NJ.
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):

References for breastfeeding information

  1. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  2. Ben-Baruch G Menczer J Goshen R Kaufman B Gorodetsky R "Cisplatin excretion in human milk" J Natl Cancer Inst 84 (1992): 451-2
  3. De Vries EG, Van der Zee AG, Uges DR, Sleijfer DT "Excretion of platinum into breast milk." Lancet 1 (1989): 497
  4. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  5. Socinski MA, Weissman C, Hart LL, et al. "Randomized phase II trial of pemetrexed combined with either cisplatin or carboplatin in untreated extensive-stage small-cell lung cancer." J Clin Oncol 24 (2006): 4840-7
  6. "Product Information. Platinol (cisplatin)." Bristol-Myers Squibb, Princeton, NJ.

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