Bosentan Pregnancy and Breastfeeding Warnings

Bosentan is also known as: Tracleer

Bosentan Pregnancy Warnings

Bosentan has been assigned to pregnancy category X by the FDA. Bosentan is expected to cause fetal harm if administered to pregnant women. Animal data have revealed teratogenicity including malformations of the head, mouth, face and large blood vessels in addition to an increased number of stillbirths and increased mortality. There are no data on the use of bosentan in human pregnancy. Bosentan is considered contraindicated for use in pregnancy. Prior to initiating therapy, pregnancy must be excluded and prevented during treatment with a reliable form of contraception. It is important to note that hormonal contraceptives, including oral, injectable, transdermal, and implantable contraceptives may not be reliable in the presence of bosentan and should not be used as the sole contraceptive method in patients receiving bosentan. Follow-up urine or serum pregnancy tests should be obtained monthly in women of childbearing potential. The patient should be advised that if there is any delay in onset of menses or any other reason to suspect pregnancy, she must notify the physician immediately for pregnancy testing. If the pregnancy test is positive, the physician and patient must discuss the risk to the pregnancy and to the fetus.

An open-label, single arm, multicenter, safety study evaluated the effect on testicular function of bosentan. Based on these findings and preclinical data from endothelin receptor antagonists, it cannot be excluded that endothelin receptor antagonists such as bosentan have an adverse effect on spermatogenesis.

Bosentan Breastfeeding Warnings

There are no data on the excretion of bosentan into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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