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Temodar and Pregnancy

If a woman uses Temodar (temozolomide) during pregnancy, it may lead to potentially serious problems in her unborn child. Although this drug has not been adequately studied in pregnant women, animal studies have shown that Temodar may cause miscarriages and various birth defects when used during pregnancy. To avoid these complications, women and men of childbearing potential should use effective birth control methods during Temodar treatment.

Can Pregnant Women Use Temodar?

Temodar® (temozolomide) 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, this medication caused miscarriages and numerous types of birth defects when given to pregnant rats and rabbits at doses that were lower than the maximum recommended human dose. Temodar has not been adequately studied in pregnant women.
This medication is generally not recommended for use in pregnant women. However, because this medicine is approved to treat serious types of cancerous brain tumors, it may be used in a pregnant woman if safer treatment options are not available.
Women of childbearing potential should avoid becoming pregnant during Temodar treatment. The manufacturer of Temodar also advises that female partners of men who take Temodar should avoid becoming pregnant. Therefore, men and women of childbearing potential should use a reliable form of birth control throughout Temodar treatment. Talk to your healthcare provider about reliable forms of birth control that may be an option for your particular situation.
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