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Gliadel and Pregnancy

Using Gliadel (carmustine implant) during pregnancy may lead to potentially serious problems in an unborn child. Although this drug has not been adequately studied in pregnant women, animal studies have shown that the active ingredient may cause miscarriages and various birth defects. However, there may be times when the benefits of this chemotherapy drug outweigh the potential risks to a fetus.

Can Pregnant Women Use Gliadel?

Gliadel® (carmustine implant) is a chemotherapy medicine approved to treat cancerous tumors of the brain. It is considered a pregnancy Category D medication, which means it may harm an unborn child if used 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 her unborn child.
In animal studies, carmustine, the active ingredient in Gliadel, increased the risk for miscarriage when given to pregnant rats and rabbits. In rats, the medication also caused birth defects, including:
  • Absence of one or both eyes
  • An underdeveloped jaw
  • 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 doses (about one-sixth the normal recommended human dose).
Gliadel has not been adequately studied in pregnant women. There are only two reports describing the use of carmustine in pregnant women. In both of these reports, the women received the medication intravenously (into a vein). One of the women received Gliadel before and during the first two trimesters of pregnancy; the other woman received it late in the second trimester. Both women delivered babies without birth defects. However, this is not enough information to say for certain that the drug is safe for use during pregnancy.
It should be noted that Gliadel is implanted directly into the brain, where it slowly dissolves and releases the medicine. At this time, it is unknown how much, if any, of the medicine is absorbed into the bloodstream, where it could be passed to an unborn baby. In addition, the amount of time it takes for the implant to dissolve can vary from person to person.
Gliadel is generally not recommended for use in pregnant women. However, because the medicine is approved to treat serious types of cancerous brain tumors, a healthcare provider may recommend its use in a pregnant woman if safer treatments are not an option.
If you wish to become pregnant after receiving a Gliadel implant, talk to your healthcare provider. He or she will recommend how long you should wait after receiving the implant before you should try to conceive.
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