Fortesta and Pregnancy

If you are pregnant, you should not use Fortesta (testosterone gel). The FDA has classified this product as a pregnancy Category X drug, based on animal studies where severe genital defects occurred in female fetuses. However, your partner may continue using the skin gel if you are pregnant, as long as precautions are taken to avoid skin-to-skin contact with the area where Fortesta was applied.

An Overview of Pregnancy and Fortesta

Fortesta™ (testosterone gel) is a prescription testosterone medication approved only for use in men. It is not safe for use by pregnant women. Men who use Fortesta should take special precautions to avoid exposing pregnant women to the drug.

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 humans who have mistakenly taken the drug when pregnant.
Because it would be unethical to give Fortesta to pregnant women, its use in pregnant women has never been studied in a clinical trial. However, we know about the problems Fortesta might cause based on problems seen with testosterone and other androgens given to pregnant animals, and based on a few cases of testosterone exposure to pregnant women.
When pregnant animals or women are exposed to androgens, there is a definite risk of masculinization of the genitals in female fetuses. The risk for the most dramatic changes occurs with early first-trimester exposure, although exposure at any time during pregnancy can cause some genital changes.

Can My Partner Use Fortesta While I Am Pregnant?

As long as you both take appropriate measures, it is fine for your partner to use Fortesta while you are pregnant. Keep in mind that you can be exposed to the drug through vigorous skin-to-skin contact with the area the gel was applied to, even for hours after it is applied.
Fortesta dries on the skin and slowly releases testosterone into the bloodstream all day long until it is washed off. If you think you have been exposed to Fortesta, wash the affected area immediately and thoroughly.
If skin-to-skin contact is anticipated, your partner must thoroughly wash the application area beforehand.
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