The FDA has classified the histrelin implant (Supprelin LA, Vantas) as a pregnancy Category X medicine because it may harm a fetus. Animal studies have shown that this medication may increase the risk for miscarriages, decreased fetal weights, and other problems. Due to the potential risks, this drug is not recommended for use in women who are pregnant or may become pregnant.
Can Pregnant Women Use Histrelin Implants?
The histrelin implant (Supprelin® LA, Vantas®) is a prescription medication approved for use in men with prostate cancer and children with central precocious puberty (early onset puberty). It is a pregnancy Category X medication because it can harm an unborn baby.
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.
Histrelin implants have not been studied in pregnant women. When given to pregnant rabbits and rats, the medication caused low fetal body weights and miscarriages. It also increased the risk for birth defects when given in high doses to pregnant rabbits.
Based on its actions in the body, histrelin implants may increase the risk for a miscarriage if taken by a pregnant woman. Histrelin works by decreasing the production of sex hormones in the body (testosterone in men and estrogen in women). Estrogen is important for a healthy pregnancy because it supports uterine growth (among other actions). Thus, a decrease in estrogen levels could cause problems for the fetus.
Histrelin implants should not be used in women who are pregnant or who may become pregnant. The medication is only approved for use in children and men. However, if a woman of childbearing potential happens to be using a histrelin implant, she should use a nonhormonal method of birth control (such as condoms) during treatment.
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