Ambrisentan Pregnancy and Breastfeeding Warnings

Ambrisentan is also known as: Letairis

Ambrisentan Pregnancy Warnings

Ambrisentan has been assigned to pregnancy category X by the FDA. Ambrisentan is expected to cause fetal harm if administered to pregnant women. Animal data have revealed teratogenicity in rats and rabbits. In both species, there were abnormalities of the lower jaw and hard and soft palate, malformation of the heart and great vessels, and failure of formation of the thymus and thyroid. Teratogenicity is a class effect of endothelin receptor antagonists. There are no data on the use of ambrisentan in human pregnancy. Ambrisentan is considered contraindicated for use in pregnancy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Pregnancy must be excluded before the initiation of treatment with ambrisentan and prevented thereafter by the use of two reliable methods of contraception.

Ambrisentan Breastfeeding Warnings

There are no data on the excretion of ambrisentan 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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