Eligard and Pregnancy
Because Eligard (leuprolide) can have harmful effects on a fetus, it is not approved for use during pregnancy. It is licensed to treat advanced prostate cancer, which is a condition that only affects men. Eligard interferes with the production of estrogen, which is important for a healthy pregnancy, so there are no circumstances when it would be given to a woman who is expecting a child.
Is Eligard Safe During Pregnancy?Eligard® (leuprolide acetate) is a prescription medication approved to manage the symptoms of advanced prostate cancer. It works by decreasing the amount of testosterone produced in the body, which slows down the growth of prostate cancer cells. This drug has been given a pregnancy Category X classification because it can harm a developing fetus.
What Is Pregnancy Category X?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.
Eligard has not been adequately studied in pregnant women. In animal studies, the active ingredient in Eligard (leuprolide) caused birth defects, including problems with development of the backbone, when given to pregnant rabbits. It also caused miscarriage and decreased fetal body weight when given to pregnant rats and rabbits.
In men, Eligard decreases the production of testosterone. In women, the drug decreases the production of estrogen. Estrogen is important during pregnancy. It helps to promote uterine growth and maintain the lining of the uterus (the womb in which the fetus develops). Because estrogen is necessary for a healthy pregnancy, taking Eligard during this time likely would increase the risk for miscarriage.
Furthermore, this medication is not approved for use in women. It is only approved to treat prostate cancer, which naturally only occurs in men.
If Eligard happens to be given to a woman of childbearing potential, it is important that pregnancy be ruled out before starting treatment. It is also important that the woman use birth control while using this medication.