Fludara and Pregnancy

Before using Fludara (fludarabine), women of childbearing potential should be aware of the potential risks this drug may pose to an unborn child. Fludara is a pregnancy Category D medicine. In animal studies, it was shown to increase the risk for miscarriages, birth defects, and other problems. In addition, women who are not pregnant are typically advised to use effective birth control during Fludara treatment.

Can Pregnant Women Receive Fludara?

Fludara® (fludarabine phosphate) is a prescription medication used to treat certain adults with a type of leukemia known as chronic lymphocytic leukemia. It is a pregnancy Category D medicine, meaning it may cause harm to your 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.
Fludara has not been adequately studied in pregnant women. In animal studies, giving the drug to pregnant rats and rabbits caused a variety of birth defects, including bone defects, heart defects, short or missing fingers or toes, and cleft palate. It also increased the risk for miscarriages and lowered the body weights of the unborn rats and rabbits.
Women of childbearing potential should use an effective form of birth control to prevent pregnancy during treatment with Fludara. Talk to your healthcare provider about the best birth control options for your particular situation.
Fludara may also damage sperm in males. It is unknown if these effects would cause abnormalities in a developing fetus. However, to reduce the chance for potential fetal harm, it is recommended that men who have female partners of childbearing potential also use birth control during and after Fludara treatment. Your healthcare provider will let you know how long after Fludara treatment you should use birth control.
Pregnancy and Pain

Fludara Chemotherapy Information

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