Testopel and Pregnancy

The FDA has classified Testopel (testosterone pellets) as a pregnancy Category X medicine, meaning it should not be used by women who are pregnant. In fact, this drug is not approved for any use in women and may cause fetal harm. As a Category X drug, the potential risks of using Testopel while expecting clearly outweigh any potential benefits.

Can Pregnant Women Receive Testopel?

Testopel® (testosterone pellets) is a prescription medication approved for testosterone replacement therapy in men with low testosterone levels. It belongs to a group of medicines known as androgens (male sex hormones). Testopel is not approved for any use in women and should not be used during pregnancy because it may harm an unborn baby.

What Is Pregnancy Category X?

Testopel is classified as a pregnancy Category X medicine. 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.
Testopel has not been studied in pregnant women. However, there are a few cases of women who took testosterone (the active ingredient in Testopel) during pregnancy. Based on these cases and the action of the medication, this product is not considered safe for use during pregnancy.
Androgens such as testosterone can cause problems with the development of the genitals in a female fetus. More specifically, the medication can cause masculinization of the external female genitals, which means the female genitals become more like male genitals.
The extent to which masculinization occurs depends largely on how much of the medicine is used and when it is given. The risk for masculinization appears to be highest when testosterone is used in the first trimester. However, some female genital abnormalities can occur with testosterone use at any time during the pregnancy.
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Testopel Drug Information

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