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Leuprolide and Pregnancy

The FDA has given a pregnancy Category X rating to leuprolide (Eligard, Lupron, Lupron Depot). This means the drug is considered unsafe for use in women who are expecting a child. Because this medicine decreases levels of estrogen (a hormone important for a healthy pregnancy), the risk of fetal problems and miscarriage is increased when a pregnant woman uses it.

Is Leuprolide Safe During Pregnancy?

Leuprolide (Eligard®, Lupron®, Lupron Depot®) is a prescription medication used for a variety of conditions in men, women, and children. It belongs to a group of drugs called gonadotropin-releasing hormone (GnRH) agonists. Leuprolide 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.
Leuprolide has not been adequately studied in pregnant women. In animal studies, it caused birth defects, including problems with the 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.
Leuprolide works by decreasing the production of sex hormones -- testosterone in men and estrogen in women. Estrogen is important for a healthy pregnancy. It helps to promote uterine growth and maintains the lining of the uterus (the womb in which the fetus develops). By decreasing estrogen levels, using leuprolide during pregnancy could potentially increase the risk for miscarriage.
Not all forms and strengths of leuprolide are approved for use in women. However, it is important to note that no leuprolide product should ever be used in pregnant women or women who may become pregnant.
Women of childbearing potential who take this medication should use a nonhormonal method of birth control during treatment. In addition, pregnancy should be ruled out before the medicine is started and periodically during treatment.
Pregnancy and Pain

Leuprolide Acetate Drug Information

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