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Busulfan Pregnancy and Breastfeeding Warnings

Busulfan is also known as: Busulfex, Myleran

Busulfan Pregnancy Warnings

There have been 6 reports of malformed infants out of 38 offspring of women exposed to busulfan.

In one case, the mother received X-ray therapy early in the first trimester, mercaptopurine until the third month and busulfan until the delivery of the malformed infant.

There have been reports in the literature of small infants being born after the mothers received busulfan during pregnancy, particularly during the third trimester. One case was reported where an infant had mild anemia and neutropenia at birth after busulfan was administered to the mother from the eighth week of pregnancy to term.

Studies on the teratogenic potential of busulfan have been carried out in four species of laboratory animals. Results indicated the drug was teratogenic to all four species.

Busulfan has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of sterility in both male and female offspring due to the absence of germinal cells in testes and ovaries. The drug interferes with spermatogenesis in experimental animals, and there have been clinical reports of sterility, azoospermia and testicular atrophy in male patients. There are no controlled data in human pregnancy. Busulfan should only be given during pregnancy when there are no alternatives and benefit outweighs risk. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, she should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving this medication.

See references

Busulfan Breastfeeding Warnings

There are no data on the excretion of busulfan into human milk. Because of the potential for tumorigenicity shown in animal and human studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

  1. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  2. Uhl N, Eberle P, Quellhorst E, Schmidt R, Hunstein W "Busulfan treatment in pregnancy. A case report with chromosome studies." Ger Med Mon 14 (1969): 383-7
  3. Johnson FD "Pregnancy and concurrent chronic myelogenous leukemia." Am J Obstet Gynecol 112 (1972): 640-4
  4. Boros SJ, Reynolds JW "Intrauterine growth retardation following third-trimester exposure to busulfan." Am J Obstet Gynecol 129 (1977): 111-2
  5. Dugdale M, Fort AT "Busulfan treatment of leukemia during pregnancy. Case report and review of the literature." JAMA 199 (1967): 131-2
  6. Nolan GH, Marks R, Perez C "Busulfan treatment of leukemia during pregnancy. A case report." Obstet Gynecol 38 (1971): 136-8
  7. Machado JP "Busulfan treatment during pregnancy." JAMA 201 (1967): 272
  8. Bishop JB, Wassom JS "Toxicological review of busulfan (Myleran)." Mutat Res 168 (1986): 15-45
  9. "Product Information. Myleran (busulfan)." Glaxo Wellcome, Research Triangle Park, NC.
  10. Shalev O, Rahav G, Milwidsky A "Reversible busulfan-induced ovarian failure." Eur J Obstet Gynecol Reprod Biol 26 (1987): 239-42
  11. Williams DW "Busulfan in early pregnancy." Obstet Gynecol 27 (1966): 738-40
  12. Abramovici A, Shaklai M, Pinkhas J "Myeloschisis in a six weeks embryo of a leukemic woman treated by busulfan." Teratology 18 (1978): 241-6

References for breastfeeding information

  1. "Product Information. Myleran (busulfan)." Glaxo Wellcome, Research Triangle Park, NC.
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.