Prostate Cancer Home > Casodex and Pregnancy
If you are pregnant or are thinking of becoming pregnant, you should not take Casodex (bicalutamide). It is unlikely that this drug would be prescribed during pregnancy in the first place, since it is not approved for use in women. Fetal risks are associated with taking this medication during pregnancy, so the FDA has given it a pregnancy Category X rating.
Casodex® (bicalutamide) is a prescription medication used in the treatment of advanced prostate cancer. It works by blocking the effects of androgens (male sex hormones). Casodex is considered a pregnancy Category X medication. It is not approved for use in women, and should not be used in women who are pregnant or may become pregnant.
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 X is given to medicines that show problems to the fetus in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the potential benefits.
Casodex has not been studied in pregnant women. In animal studies, Casodex caused birth defects of the external genitals in male offspring when given to pregnant rats. Based on the actions of the medication in the body and the results of animal studies, the drug may cause fetal harm, including abnormalities of the genitals in a male fetus.
Casodex is not approved for use in women at all, including women who are pregnant. If taken during pregnancy, it may cause birth defects. Therefore, if you are pregnant or thinking about becoming pregnant, let your healthcare provider know right away. You should not take Casodex.