Leukemia Home > Busulfex and Pregnancy

As a pregnancy Category D medication, Busulfex (busulfan injection) may not be safe for pregnant women. Although adequate research has not been done in pregnant women, there have been reports of numerous birth defects occurring in the babies of mothers who used this drug during pregnancy. However, there may be situations when the benefits of using the drug outweigh the possible risks to the unborn child.

Can Pregnant Women Receive Busulfex?

Busulfex® (busulfan injection) is a prescription medicine used to prepare the body for stem cell transplantation in people with a type of blood cell cancer known as chronic myelogenous leukemia. It is a pregnancy Category D medicine, which means it may harm an unborn child if taken during pregnancy.

What Is Pregnancy Category D?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
In animal studies, Busulfex caused a variety of problems when given to pregnant mice, rats, and rabbits, including abnormal development of the muscles and bones and reduced fetal body weight and size. The medication also caused sterility (the inability to have children) in the male and female offspring when given to pregnant rats.
Busulfex comes as a solution to be given as an injection. It contains the chemical dimethylacetamide (DMA). DMA is a solvent. It is used to dissolve the active ingredient in Busulfex to make a liquid for injection. When given to pregnant rats, DMA has been shown to cause a variety of problems in the fetal rats, including:
  • Heart defects
  • Abnormal development of the ribs and vertebrae
  • Generalized swelling
  • Cleft palate.
Busulfex and DMA have not been adequately studied in pregnant women. However, there are several reports describing the use of busulfan (the active ingredient in Busulfex) during pregnancy. In many of these reports, women delivered healthy babies even though they took the medication during pregnancy. In other cases, babies of women receiving busulfan were born with birth defects, including defects of the:
  • Liver
  • Spleen
  • Kidneys
  • Lungs
  • Eyes
  • Ovaries
  • Thyroid gland
  • Roof of the mouth (cleft palate).
The use of Busulfex during pregnancy has also been associated with smaller-than-normal babies, especially when used in the third trimester. The medication may also cause a newborn to have anemia and low white blood cell counts, which are common side effects of treatment.
Women of childbearing potential should use an effective form of birth control to avoid becoming pregnant during Busulfex treatment. Many women may have irregular menstrual periods during treatment. If this happens to you, do not assume you cannot become pregnant. You should still use birth control.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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