Doxorubicin Pregnancy and Breastfeeding Warnings

Doxorubicin is also known as: Adriamycin, Adriamycin PFS, Adriamycin RDF

Doxorubicin Pregnancy Warnings

Doxorubicin has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryotoxicity and teratogenicity. Although controlled data from human pregnancy studies are not available, several cases of birth defects have been associated with the use of doxorubicin. Some experts feel that the use of doxorubicin for the treatment of breast cancer during pregnancy improves the high postpartum maternal mortality rate and the chance of producing live births without excessive risk to the fetus or the mother, even if administered early in the course of pregnancy. Doxorubicin should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Doxorubicin crosses the human placenta. Several cases of birth defects have been associated with the use of doxorubicin during pregnancy. These birth defects have included imperforate anus, rectovaginal fistula, brachycephaly, hypoplasia of the anterior cranial base and face, synostoses of cranial sutures, hypoplastic digits, and fetal maceration. Fetal death has been reported 36 hours after treatment with doxorubicin and other neoplastic agents. Doxorubicin may cause reversible testicular and ovarian dysfunction or menstrual abnormalities. Most men who have received doxorubicin regain spermatogenesis and sperm motility. Some women who were previously treated with doxorubicin have subsequently had normal pregnancies. Development of sterility may depend on the dose, duration of therapy, and the pretreatment state of gonadal function. Pregnancy outcome in women who received doxorubicin for malignancy in childhood has been reported to generally be favorable. Those with baseline left ventricular dysfunction should be considered at increased risk for worse pregnancy outcome and further deterioration in myocardial function. Peripartum heart failure has been reported years after doxorubicin therapy. Pregnancy, preeclampsia, anemia, or overhydration are possible precipitating factors in the emergence of heart failure in patients who have received doxorubicin. While there are no data regarding the handling of doxorubicin or other cytotoxic agents by women who are pregnant, attempting to conceive, or breast-feeding, some experts suggest the need for caution.

Doxorubicin Breastfeeding Warnings

Peak milk concentrations of doxorubicin and its metabolite, doxorubicinol, averaged 128 and 111 ng/mL, respectively, 24 hours after a 70 mg/m2 IV dose was given to a 31 year old nursing woman. The milk to plasma concentration ratio at 24 hours was 4.43. Although doxorubicin concentrated into milk in this case, the absolute concentration of drug in the milk was only 0.24 mcg/mL. Although this amount appears negligible, experts consider the use of doxorubicin during breast-feeding to be contraindicated because of the known and suspected risks to the nursing infant.

Doxorubicin is excreted into and accumulates in human milk. Side effects, including immune suppression, carcinogenesis, neutropenia, and unknown effects on growth are possible in nursing infants. The American Academy of Pediatrics considers the use of doxorubicin to be contraindicated during breast-feeding.

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