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BiCNU and Pregnancy

If a woman receives BiCNU (carmustine) during pregnancy, it may put her unborn child at risk. Although this drug has not been adequately studied in pregnant women, it has been shown to increase the risk for miscarriage and birth defects during animal studies. However, there may be situations where the benefits to the mother outweigh the risks to the fetus.

Can Pregnant Women Use BiCNU?

BiCNU® (carmustine) is a prescription chemotherapy medication. It is considered a pregnancy Category D medicine, which means it may cause harm to an unborn child if used by a pregnant woman.

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 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 her unborn child.
In animal studies, BiCNU increased the risk for miscarriage when given to pregnant rats and rabbits at doses that were similar to the recommended human dose. It also caused birth defects in rats, including absence of one or both eyes, an underdeveloped jaw, and defects of the abdominal (stomach) wall in which the intestines, liver, or other nearby organs stick out of the belly button. These defects occurred even at low doss (about one-sixth the normal recommended human dose).
This drug has not been adequately studied in pregnant women. There are only two reported cases describing the use of BiCNU in pregnant women.
In one of these cases, the woman received the medicine during the first two trimesters of pregnancy. In the other, the woman received the medicine late in the second trimester. Both women delivered babies without birth defects. However, two reports is not nearly enough information to say for certain that the drug is safe for use during pregnancy.
BiCNU is generally not recommended for use in pregnant women. However, because BiCNU is approved to treat serious types of cancer, the medication may be used in a pregnant woman if safer treatment options are not available.
Women of childbearing potential should use a reliable form of birth control to avoid becoming pregnant during BiCNU treatment. Talk to your healthcare provider about birth control options for your particular situation.
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