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Novantrone and Pregnancy

Women who are going through treatment with Novantrone (mitoxantrone) must use an effective form of birth control, as this medication can harm an unborn child. The FDA has classified Novantrone as a pregnancy Category D medicine, meaning it should only be given to a pregnant woman if the benefits clearly outweigh the risks to the unborn child.

 

Can Pregnant Women Use Novantrone?

Novantrone® (mitoxantrone) is a medicine prescribed to treat multiple sclerosis and certain types of cancer. It may not be safe to use during pregnancy, as this drug may harm an unborn child.
 

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 specific medicine is taken during pregnancy. Novantrone is classified as a pregnancy Category D medicine.
 
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.
 
Novantrone has not been adequately studied in pregnant women. In animal studies, the drug impaired fetal growth and kidney development when given to pregnant rats. It also caused premature delivery when given to pregnant rabbits.
 
Novantrone did not appear to increase the risk for birth defects in animal studies. However, the highest doses tested were well below the maximum recommended human dose. Therefore, it is not entirely known whether higher amounts would cause additional problems.
 
Women of childbearing potential should use an effective form of birth control to avoid pregnancy during Novantrone treatment. These women should also have a negative pregnancy test before receiving the medicine, even if they are using adequate birth control. 
 
Pregnancy and Pain

Novantrone Medication Information

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