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Striant is not approved for use in women, particularly those who are expecting. Due to the risk of potentially serious problems, Striant (testosterone buccal tablet) should not be used during pregnancy. 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.
An Overview of Pregnancy and StriantStriant™ (testosterone buccal tablet) is a prescription testosterone medication approved only for use in men. It is not safe for use by pregnant women.
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 medicine.
Because it would be unethical to give Striant to pregnant women, its use in pregnant women has never been studied in a clinical trial. However, we know about the problems Striant might cause based on problems seen with testosterone or 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.
It appears that the risk of testosterone exposure through kissing a partner who is using Striant is quite small, since the drug is absorbed directly from the tablet into the gums, not through saliva. There are no special precautions that prevent kissing in such situations.