Axiron and Pregnancy
Women in general -- and pregnant women in particular -- should not use Axiron, a topical testosterone product approved only for men. The FDA has given this drug a pregnancy Category X rating, meaning it could lead to serious problems, such as masculinization of the genitals in female fetuses. If your partner uses Axiron, take precautions to prevent exposure to this medicine.
Axiron® (testosterone topical solution) is a prescription medication approved only for use in men. It contains testosterone and is not safe for use by pregnant women in any situation. Pregnant women should not intentionally use Axiron and should be very careful to prevent unintentional exposure to the drug.
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 medicine.
When pregnant animals or women are exposed to androgens (like Axiron), 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.
Because it would be unethical to give Axiron to pregnant women, its use in pregnant women has never been studied in a clinical trial. However, we know about the problems Axiron might cause based on problems seen with testosterone or other androgens given to pregnant animals, and based on a few cases of testosterone exposure in pregnant women.