Zoladex and Pregnancy
The FDA has given a pregnancy Category D rating to Zoladex (goserelin acetate implant) when used in women with advanced breast cancer, and a Category X rating for all other uses. This means that this drug should only be used in pregnant women with breast cancer when the benefits outweigh the risks of miscarriage and fetal harm. The drug should not be used in any other cases.
Can Pregnant Women Use Zoladex?Zoladex® (goserelin acetate implant) is a prescription hormone medication that decreases the production of sex hormones (estrogen and testosterone) in the body. It is used to treat breast cancer, endometriosis, and irregular uterine bleeding in women. The higher strength of Zoladex is used in men with prostate cancer.
Based on animal studies, as well as the expected action of Zoladex in the body, this drug can harm an unborn baby and increase the risk for miscarriage if taken during pregnancy. Zoladex is a pregnancy Category D medication when used in women with advanced breast cancer, and a pregnancy Category X medication for all other uses.
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 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.
What Is Pregnancy Category X?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.