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Cytarabine Pregnancy and Breastfeeding Warnings

Cytarabine is also known as: Cytosar, Cytosar-U, Tarabine PFS

Cytarabine Pregnancy Warnings

The manufacturer has noted a review of the literature in which 32 cases where cytarabine was administered during pregnancy have been reported. Eighteen normal infants were delivered. Five infants were premature or had low birth weight. One of the apparently normal infants died at ninety days of gastroenteritis. Two cases of congenital abnormalities were reported. One of the cases had upper and lower distal limb defects, and the other case had extremity and ear deformities. Seven of the infants had various problems in the neonatal period. These problems included pancytopenia, transient depression of WBC, hematocrit, or platelets, electrolyte abnormalities, transient eosinophilia, and one case of increased IgM levels and hyperpyrexia (possibly due to sepsis). Six of the seven infants were also premature. The child with pancytopenia died of sepsis at 21 days. Therapeutic abortions were reported to have been done in five cases. Four of these five fetuses were grossly normal. However, one had an enlarged spleen and another showed Trisomy C chromosome abnormality in the chorionic tissue.

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

See references

Cytarabine Breastfeeding Warnings

There are no data on the excretion of cytarabine into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions due to cytarabine in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

  1. "Product Information. DepoCyt (cytarabine)." Chiron Therapeutics, Emeryville, NY.
  2. "Product Information. Cytosar-U (cytarabine)." Pharmacia and Upjohn, Kalamazoo, MI.
  3. Maurer LH, Forcier RJ, McIntyre OR, Benirschke K "Fetal group C trisomy after cytosine arabinoside and thioguanine." Ann Intern Med 75 (1971): 809-10

References for breastfeeding information

  1. "Product Information. DepoCyt (cytarabine)." Chiron Therapeutics, Emeryville, NY.
  2. "Product Information. Cytosar-U (cytarabine)." Pharmacia and Upjohn, Kalamazoo, MI.

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