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The FDA has given Methitest (methyltestosterone tablets) a pregnancy Category X rating, which means it is considered unsafe during pregnancy. When female fetuses are exposed to androgens, such as this medication, there is an increased risk of masculinization of the genitals, especially during the first trimester. If you have taken or been exposed to this drug during pregnancy, tell your healthcare provider right away.
Methitest® (methyltestosterone tablets) is a prescription medication used for testosterone replacement therapy. It contains methyltestosterone and is not safe for use by pregnant women in any situation. Methitest is approved for women only for the treatment of certain cases of late-stage breast cancer.
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 pregnant humans who have mistakenly taken a medicine.
When pregnant animals or women are exposed to androgens (like Methitest), 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 Methitest to pregnant women, its use in this group has never been studied in a clinical trial. However, we know about the problems Methitest might cause based on problems seen with methyltestosterone or other androgens given to pregnant animals and based on a few cases of testosterone exposure in pregnant women.