Emcyt and Pregnancy
The prostate cancer drug Emcyt (estramustine) is not approved for use in women. Therefore, it will not likely be given to women who are pregnant. Emcyt has not been studied in pregnant women; however, estradiol has been shown to cause birth defects and other complications. It is generally recommended that men who use this medication, along with their female partners, use an effective form of birth control.
Can Pregnant Women Take Emcyt?Emcyt® (estramustine phosphate) is a prescription medication used in the treatment of prostate cancer. It combines estradiol (a form of estrogen) with a chemotherapy medicine known as nornitrogen mustard. Emcyt is only approved for use in men, and may harm an unborn child if taken by a pregnant woman.
More Information on Emcyt and PregnancyThe 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. Most medications are assigned to a risk category based on animal or human studies and on whether the potential risks of using the medication during pregnancy outweigh the potential benefits.
Technically, Emcyt has not been given a pregnancy category rating. This drug has not been adequately studied in pregnant woman. However, estradiol is considered a pregnancy Category X medication. 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.
A study that looked at possible birth defects in 29 infants whose mothers took estradiol in the first trimester of pregnancy found four major birth defects, including heart defects. One birth defect was expected by chance. However, other studies have not demonstrated an increased risk for birth defects from estradiol use during pregnancy.
Medications similar to the chemotherapy drug portion of Emcyt (nitrogen mustards) are generally considered pregnancy Category D medications. Pregnancy Category D is a classification 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. Many of these medicines have been shown to cause problems, such as kidney defects, in animal studies and in humans.
At this time, it is not entirely known what types of problems Emcyt may cause if taken during pregnancy. Because there is no well-accepted medical reason for a pregnant woman to take it, and because the risks are not fully known, Emcyt should not be used during pregnancy. In addition, the manufacturer recommends that men who use the medication, as well as their female partners, should use an adequate form of birth control to avoid pregnancy.