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Doxorubicin Pregnancy and Breastfeeding Warnings

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

Medically reviewed on December 28, 2016

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.

See references

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.

See references

References for pregnancy information

  1. Newcomb M, Balducci L, Thigpen JT, Morrison FS "Acute leukemia in pregnancy. Successful delivery after cytarabine and doxorubicin." JAMA 239 (1978): 2691-2
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  3. Gershenson DM "Menstrual and reproductive function after treatment with combination chemotherapy for maligmant ovarian germ cell tumors." J Clin Oncol 6 (1988): 270-5
  4. Gililland J, Weinstein L "The effects of cancer chemotherapeutic agents on the developing fetus." Obstet Gynecol Surv 38 (1983): 6-13
  5. Karp GI, von Oeyen P, Valone F, Khetarpal VK, Israel M, Mayer RJ, Frigoletto FD, Garnick MB "Doxorubicin in pregnancy: possible transplacental passage." Cancer Treat Rep 67 (1983): 773-7
  6. Lendon M, Hann IM, Palmer MK, Shalet SM, Jones PH "Testicular histology after combination chemotherapy in childhood for acute lymphoblastic leukaemia." Lancet 2 (1978): 439-41
  7. Davis LE, Brown CE "Peripartum heart failure in a patient treated previously with doxorubicin." Obstet Gynecol 71 (1988): 506-8
  8. Dara P, Slater LM, Armentrout SA "Successful pregnancy during chemotherapy for acute leukemia." Cancer 47 (1981): 845-6
  9. Awidi AS, Tarawneh MS, Shubair KS, Issa AA, Dajani YF "Acute leukemia in pregnancy: report of five cases treated with a combination which included a low dose of adriamycin." Eur J Cancer Clin Oncol 19 (1983): 881-4
  10. Tobias JS, Bloom HJ "Doxorubicin in pregnancy." Lancet 1 (1980): 776
  12. Roboz J, Gleicher N, Wu K, Chanihian P, Kerenyi T, Holland J "Does doxorubicin cross the placenta?." Lancet 2 (1979): 1382-3
  13. Radford JA, Clark S, Crowther D, Shalet SM "Male fertility after VAPEC-B chemotherapy for Hodgkin's disease and non-Hodgkin's lymphoma." Br J Cancer 69 (1994): 379-81
  14. Murray CL, Reichart JA, Anderson J, Twiggs LB "Multimodal cancer therapy for breast cancer in the first trimester of pregnancy: a case report." JAMA 252 (1984): 2607-8
  15. Drasga RE, Einhorn LH, Williams SD, Patel DN, Stevens EE "Fertility after chemotherapy for testicular cancer." J Clin Oncol 1 (1983): 179-83
  16. Martin RH, Rademaker AW, Leonard NJ "Analysis of chromosomal abnormalities in human sperm after chemotherapy by karyotyping and fluorescence in situ hybridization (FISH)." Cancer Genet Cytogenet 80 (1995): 29-32
  17. Pizzuto J, Aviles A, Noriega L, Niz J, Morales M, Romero F "Treatment of acute leukemia during pregnancy: presentation of nine cases." Cancer Treat Rep 64 (1980): 679-83
  18. Rustin GJ, Booth M, Dent J, Salt S, Rustin F, Bagshawe KD "Pregnancy after cytotoxic chemotherapy for gestational trophoblastic tumours." Br Med J 288 (1984): 103-6
  19. Fassas A, Kartalis G, Klearchou N, Tsatalas K, Sinacos Z, Mantalenakis S "Chemotherapy for acute leukemia during pregnancy. Five case reports." Nouv Rev Fr Hematol 26 (1984): 19-24
  20. d'Incalci M, Broggini M, Buscaglia M, Pardi G "Transplacental passage of doxorubicin." Lancet 1 (1983): 75
  21. Dobbing J "Pregnancy and leukemia." Lancet 1 (1977): 1155
  22. Da Cunha MF, Meistrich ML, Ried HL, Gordon LA, Watchmaker G, Wyrobek AJ "Active sperm production after cancer chemotherapy with doxorubicin." J Urol 130 (1983): 927-30
  23. Garcia V, Miguel JS, Borrasca AL "Doxorubicin in the first trimester of pregnancy." Ann Intern Med 94 (1981): 547
  24. Sutton R, Buzdar AU, Hortobagyi GN "Pregnancy and offspring after adjuvant chemotherapy in breast cancer patients." Cancer 65 (1990): 847-50
  25. Pratt CB, Rivera G, Shanks E "Osteosarcoma during pregnancy." Obstet Gynecol 50(1 Suppl) (1977): s24-6
  26. Garcia V, Miguel JS, Borrasca AL "Doxorubicin in the first trimester of pregnancy." Ann Intern Med 94 (1981): 547
  27. Khurshid M, Saleem M "Acute leukemia in pregnancy." Lancet 2 (1978): 534-5
  28. Bar J, Davidi O, Goshen Y, Hod M, Yaniv I, Hirsch R "Pregnancy outcome in women treated with doxorubicin for childhood cancer." Am J Obstet Gynecol 189 (2003): 853-857
  29. Artlich A, Moller J, Tschakaloff A, Schwinger E, Kruse K, Gortner L "Teratogenic effects in a case of maternal treatment for acute myelocytic leukaemia--neonatal and infantile course." Eur J Pediatr 153 (1994): 488-91
  30. "Product Information. Adriamycin PFS (doxorubicin)." Pharmacia and Upjohn, Kalamazoo, MI.
  31. Turchi JJ, Villasis C "Anthracyclines in the treatment of malignancy in pregnancy." Cancer 61 (1988): 435-40

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. "Product Information. Adriamycin PFS (doxorubicin)." Pharmacia and Upjohn, Kalamazoo, MI.
  3. Egan PC, Costanza ME, Dodion P, Egorin MJ, Bachur NR "Doxorubicin and cisplatin excretion into human milk." Cancer Treat Rep 69 (1985): 1387-89

Further information

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