Cancer Home > Zolinza and Pregnancy

Before undergoing treatment with Zolinza (vorinostat), women should be aware of the risks this drug may pose to an unborn child. Because animal studies have shown that this drug can cause problems, such as miscarriage and bone defects, Zolinza is classified as a pregnancy Category D medicine. This means that it should only be given to a pregnant woman if the benefits outweigh the risks.

Can Pregnant Women Take Zolinza?

Zolinza® (vorinostat) is a prescription medication approved to treat cutaneous T-cell lymphoma, a cancer of the blood that affects the skin. It is used when other treatments have not adequately controlled the condition. Zolinza 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. Zolinza is classified as a pregnancy Category D medicine.
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.
Zolinza has not been adequately studied in pregnant women. In animal studies, the drug decreased fetal weight and caused bone defects, including defects of the skull, ribs, and vertebra, when given to pregnant rats and rabbits, even at low doses. In addition, it increased the risk for defects of the gallbladder when given to pregnant rabbits, and caused miscarriage when given in early pregnancy to rats.
In general, this medicine should not be used in pregnant women unless absolutely necessary, such as in cases where a safer treatment option does not exist. Women who receive Zolinza should use an effective form of birth control to prevent pregnancy throughout treatment. Your healthcare provider can talk to you about the best contraceptive method for your particular situation.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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