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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.

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.

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