Losartan Pregnancy and Breastfeeding Warnings

Losartan is also known as: Cozaar

Losartan Pregnancy Warnings

Losartan has been assigned to pregnancy category D by the FDA. Animal data have shown that the use of losartan produces adverse effects in rat fetuses and neonates, including decreased body weight, delayed physical and behavioral development, death and renal toxicity. With the exception of neonatal weight gain (which was affected at doses as low as 10 mg/kg/day), doses associated with these effects exceeded 25 mg/kg/day (approximately 3 times the maximum recommended human dose of 100 mg [on a mg/m2 basis]). These findings are attributed to drug exposure in late gestation and during lactation. There are no controlled data in human pregnancy. Drugs acting directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. Losartan is considered contraindicated during pregnancy.

Drugs that act directly on the renin-angiotensin 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, losartan should be discontinued as soon as possible. The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy 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 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. These adverse effects do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester. Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist only during the first trimester should be informed. Nonetheless, when patients become pregnant, physicians should have the patient discontinue the use of losartan as soon as possible.

Losartan Breastfeeding Warnings

There are no data on the excretion of losartan into human milk. Animal data have shown significant levels of losartan and its active metabolite in rat milk after doses ranging from 10 to 25 mg/kg/day. 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 mother.

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