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Dactinomycin Pregnancy and Breastfeeding Warnings

Dactinomycin is also known as: Cosmegen

Dactinomycin Pregnancy Warnings

A few retrospective pregnancy outcome studies have been reported. A retrospective study of 8 women who had received dactinomycin in childhood or adolescence revealed an incidence of congenital abnormalities of 15% (3/20) among 20 live births. Two of the affected children suffered congenital heart disease. In a letter to the editor, representatives from the National Cancer Institute (NCI) responded to the unexpected findings in the study above. They determined the occurrence of birth defects among the offspring of similar survivors studied at five centers by the NCI. None of the 52 offspring born to 36 survivors (11 men and 25 women) who had been treated with dactinomycin had a major birth defect, whereas 74 of the 2,146 offspring of unexposed survivors had major malformations, including 17 children with congenital heart disease. They concluded that, although in experimental systems dactinomycin is both a mutagen and a teratogen, there is not an association between exposure to dactinomycin and congenital heart defects. A retrospective analysis of 49 women who had received chemotherapy for gestational trophoblastic disease included 45 who received methotrexate (MTX) monotherapy and four who received combination therapy consisting of MTX and dactinomycin, one of whom also received cyclophosphamide. The 49 women became pregnant 65 times, resulting in 42 (65%) live term births, 4 (6.1%) premature births, 1 (1.5%) stillbirth, 8 (2.3%) spontaneous abortions, 7 (10.8%) elective abortions, and 3 (4.6%) recurrent molar pregnancies. No congenital malformations or obstetric complications were observed. Relationships between premature birth, stillbirth, or spontaneous abortion and dactinomycin were not made. Normal fertility (in males and females) and pregnancies have been reported after the use of dactinomycin to prevent or treat malignancies. Dactinomycin-induced gonadal dysfunction appears to be reversible in the majority of patients. Limited data have shown that there may be serious complications in newborns who received dactinomycin. These data suggest the increased risk of toxicity in this age group may preclude its use during pregnancy.

Dactinomycin has been assigned to pregnancy category D by the FDA. Animal data have revealed evidence of malformations and embryotoxicity. There are no controlled data in human pregnancy; however, use of bleomycin during pregnancy may cause fetal harm. If dactinomycin is used during pregnancy or if the patient becomes pregnant during treatment, the patient should be advised of the potential hazard to the developing fetus. Women of childbearing potential should be advised to avoid pregnancy during treatment with dactinomycin.

Dactinomycin Breastfeeding Warnings

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

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