Irbesartan Pregnancy and Breastfeeding Warnings

Irbesartan is also known as: Avapro

Irbesartan Pregnancy Warnings

Irbesartan has been assigned to pregnancy category D by the FDA. Animal data have revealed evidence of fetotoxicity (renal pelvic cavitation, hydroureter and/or absence of renal papilla) after doses equivalent to maximum recommended human doses (MRHD) and maternal mortality and abortion after doses equivalent to 1.5 times the MRHD after correction for body surface area. Surviving females receiving 1.5 times the MRHD were observed to have an increased incidence of early fetal resorptions and a corresponding decrease in live births. Drugs acting directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. Use of irbesartan during pregnancy is considered contraindicated.

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, irbesartan 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. Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist, such as irbesartan, only during the first trimester should be informed. Nonetheless, when a patient becomes pregnant, it is strongly recommended that physicians discontinue the use of irbesartan as soon as possible.

Irbesartan Breastfeeding Warnings

There are no data on the excretion of irbesartan into human milk. 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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