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Eprosartan Pregnancy and Breastfeeding Warnings

Eprosartan is also known as: Teveten

Eprosartan Pregnancy Warnings

Eprosartan has been assigned to pregnancy category D by the FDA for use during the second and third trimesters and to category C during the first trimester. Animal and human data have revealed evidence of embryolethality and teratogenicity associated with drugs that act directly on the renin-angiotensin system. There are no controlled data in human pregnancy. Use of eprosartan during pregnancy is considered contraindicated unless no alternative treatment can be found.

Drugs that act directly on the renin-angiotensin-aldosterone (RAA) system can cause fetal and neonatal morbidity and death when administered during pregnancy. Several dozen cases have been reported in the world literature in patients who were taking angiotensin converting enzyme (ACE) inhibitors. A committee of the National Institutes of Health has recommended that these drugs be avoided during pregnancy. When pregnancy is detected or expected, eprosartan should be discontinued as soon as possible. The use of drugs that act directly on the RAA system during the second and third trimesters has 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 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 use of these drugs. These adverse effects do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester; however first trimester use of ACE inhibitors, a specific class of drugs acting on the renin angiotensin system, was associated with a potential risk of birth defects. Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist, such as eprosartan, only during the first trimester should be informed.

Eprosartan Breastfeeding Warnings

There are no data on the excretion of eprosartan into human milk; however the drug is excreted into the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the nursing mother.

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