Vantas and Pregnancy
As a pregnancy Category X medicine, Vantas (histrelin implant) may cause harm to a fetus if used during pregnancy. 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.
Vantas® (histrelin implant) is a prescription medication approved to help treat the symptoms of advanced prostate cancer. It comes as an implant that is inserted just beneath the skin of the upper arm, and slowly releases medicine into the bloodstream for 12 months. Vantas is considered a pregnancy Category X medicine because it may harm an unborn child if taken during pregnancy.
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.
Vantas has not been adequately studied in pregnant women. However, in animal studies, this drug increased the risk for birth defects when given in high doses (up to three times the equivalent normal human dose) to pregnant rabbits. The drug also caused miscarriages, as well as decreased fetal weights, in rabbits and rats.
Vantas reduces levels of testosterone (in males) and estrogen (in females). Estrogen is vital for maintaining pregnancy and for helping the fetus develop. By depleting estrogen levels, Vantas increases the risk for miscarriage.
Vantas may cause miscarriage if taken during pregnancy. It is not approved for use in women and should not be used in pregnant women or women who may become pregnant. If you are pregnant, or thinking about becoming pregnant while using Vantas, talk to your healthcare provider.