Tracleer and Pregnancy
Tracleer (bosentan) should not be used during pregnancy. Studies have shown that the potential risks of using this drug while pregnant clearly outweigh the benefits. In animal studies, this drug caused various birth defects. Women who take Tracleer must use at least two reliable forms of birth control during treatment.
Can Pregnant Women Take Tracleer?
Based on animal studies, Tracleer® (bosentan) is not safe for use by women who are pregnant or may become pregnant. Because of the possible risks for serious birth defects, the medication has been given a pregnancy Category X classification.
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 human use of the medication. With this category, the potential risks clearly outweigh the potential benefits.
In animal studies, Tracleer increased the risk for birth defects when given to pregnant rats, including defects of the head, mouth, face, and blood vessels. This drug has not been studied in pregnant women.
Women who are pregnant or who may become pregnant should not use Tracleer. If you are a woman of childbearing potential, you will need to have a negative pregnancy test before starting the medicine. You will also need to have monthly pregnancy tests throughout treatment to make sure you have not become pregnant.
Birth defects from Tracleer can happen early in pregnancy. Therefore, you should contact your healthcare provider right away if you have a late menstrual period or if you suspect you may be pregnant. If you become pregnant during treatment, your healthcare provider will discuss the potential risks with you.
It should be noted that Tracleer can make hormonal contraceptives less effective (see Tracleer Drug Interactions). This includes any birth control methods that rely on estrogen and/or progestin, such as birth control pills, patches, injections, or implants. A woman of childbearing potential should not rely on hormonal birth control as her only birth control method.
The manufacturer of Tracleer recommends that women of childbearing potential use two reliable forms of birth control during treatment and for at least one month after treatment ends. However, women who have had tubal sterilization or use a copper intrauterine device (IUD) or certain levonorgestrel-releasing intrauterine systems (such as Mirena®) do not need to use another form of birth control. Talk to your healthcare provider about the best birth control options to use during treatment.