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Myleran and Pregnancy

It is usually recommended that women use an effective form of birth control during chemotherapy treatment with Myleran (busulfan). This prescription medicine is classified as a pregnancy Category D medication, which means it may cause fetal harm. Because Myleran caused birth defects in some cases, it should only be taken during pregnancy if the benefits to the mother outweigh the risks to her unborn child.

Can Pregnant Women Take Myleran?

Myleran® (busulfan) is a prescription medicine used in the treatment of 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 the healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.
In animal studies, Myleran caused sterility (the inability to have children) in male and female offspring when given to pregnant rats. Humans may not have the same risk, as there have not been reports of sterility in children born to women who received Myleran during pregnancy.
Although the drug has not been adequately studied in pregnant woman, there are several reports describing the use of Myleran during pregnancy. In many of these reports, women delivered healthy babies despite taking this drug during pregnancy. In other cases, however, the babies were born with a variety of birth defects, such as defects of the:
  • Liver
  • Spleen
  • Kidneys
  • Lungs
  • Eyes
  • Ovaries
  • Thyroid gland
  • Roof of the mouth (cleft palate).

The use of Myleran 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.

Women of childbearing potential should use an effective form of birth control to avoid becoming pregnant during Myleran treatment. Many women may have irregular menstrual periods during treatment. It is still important to use birth control, as you could still become pregnant even if you stop having periods while taking this medicine. Talk to your healthcare provider about the best form of birth control for your particular situation.
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