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Azilsartan medoxomil Pregnancy and Breastfeeding Warnings

Azilsartan medoxomil is also known as: Edarbi

Azilsartan medoxomil Pregnancy Warnings

The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy have been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the drug. Azilsartan is considered contraindicated during pregnancy. Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist only during the first trimester should be informed. When patients become pregnant, physicians should have the patient discontinue the use of azilsartan as soon as possible. FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: D Use of drug is not recommended. Use of adequate methods of contraception should be encouraged.

Azilsartan medoxomil Breastfeeding Warnings

A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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