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Lysteda and Pregnancy

Lysteda is used to treat heavy menstrual bleeding, and is therefore not recommended for women who are pregnant. Lysteda is classified as a pregnancy Category B medication; animal studies suggest that taking it during pregnancy would not cause problems. In fact, tranexamic acid (the active ingredient) has been used in pregnant women to treat other types of bleeding.

Is Lysteda Safe During Pregnancy?

Lysteda™ (oral tranexamic acid) is a prescription medication approved for the treatment of heavy menstrual bleeding. Therefore, it is not approved for use in pregnant women (who do not have menstrual periods). However, based on the results of animal studies, the medication appears to be safe for use during pregnancy.

What Is Pregnancy Category B?

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 B is given to medicines that have not been adequately studied in pregnant humans but do not appear to cause harm to the fetus in animal studies. Medications that have been shown to be safe for use in pregnancy in humans but have caused problems in laboratory animals are also given a Pregnancy Category B rating.
Studies in animals suggest that Lysteda is safe for use during pregnancy. In addition, tranexamic acid has been successfully used to treat bleeding (usually due to bleeding disorders) in pregnant women.
Women who take this medication to treat bleeding during pregnancy should be fully aware that Lysteda is not approved for such uses. There is some concern that the medicine could cause problems (such as blood clots in the mother, the placenta, or the fetus), but these concerns are theoretical at best. Lysteda does cross the placenta.

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Last reviewed by: Kristi Monson, PharmD
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