Prostate Cancer Home > Flutamide and Pregnancy

When given to pregnant rats and rabbits, flutamide (Eulexin) caused several problems in the offspring, such as abnormal vertebral development. Based on the results of these animal studies, the FDA considers this medication a pregnancy Category D drug. Flutamide is not approved for women, so a healthcare provider would be unlikely to recommend it, and then only if the benefits clearly outweighed the risks.

Can Women Who Are Pregnant Take Flutamide?

Flutamide (Eulexin®) is a prescription medication approved to treat prostate cancer. It is considered a pregnancy Category D medication, which means it may harm an unborn child if taken 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 the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
In animal studies, flutamide decreased offspring survival when given in high doses to pregnant rats and rabbits. It also increased the risk for abnormal development of the sternum and vertebrae bones in the rat fetus, and led to female sexual development in male rat babies.
Flutamide is not approved for use in women, including pregnant women. Although it may be used "off-label" in some women, it should not be used for nonserious conditions in pregnant women because it may harm a developing fetus.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
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