Enalapril Pregnancy and Breastfeeding Warnings
Enalapril Pregnancy Warnings
There are no controlled data in human pregnancy. Congenital malformations have been reported with the use of ACE inhibitors during the first trimester of pregnancy, while fetal and neonatal toxicity, death, and congenital anomalies have been reported with the use of ACE inhibitors during the second and third trimesters of pregnancy. If the patient becomes pregnant, enalapril should be discontinued as soon as possible. Enalapril 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. A committee of the National Institutes of Health has recommended that these drugs be avoided during pregnancy. Limited data have shown an association between major congenital malformations and the use of ACE inhibitors during the first trimester. In addition, 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 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. Mothers whose embryos and fetuses are exposed to an ACE inhibitor during the first trimester should be informed of the risks. When pregnancy is detected or expected, enalapril should be discontinued as soon as possible. A 30-year-old woman with hypertension received enalapril and furosemide throughout gestation. At 20 weeks gestation, oligohydramnios, multicystic fetal kidneys, and a small fetal thorax were detected. At 37 weeks gestation, when the mother developed proteinuria and dyspnea at rest, uncomplicated labor was induced with prostaglandins. She delivered a live 2.8 kg male who died at 10 minutes of life due to respiratory failure. A limited autopsy revealed low set ears, small epicanthic folds, bilateral talipes, a markedly bell-shaped thorax, severe renal cystic dysplasia, and a normal karyotype. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. 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: -Enalapril oral tablets and injection solution: D (for use during the second and third trimesters) and C (during the first trimester) -Enalapril oral solution: D Enalapril should be discontinued as soon as possible if a patient becomes pregnant. If there is no alternative to therapy with drugs affecting the renin-angiotensin system, apprise the mother of the potential risk to the fetus. Serial ultrasound examinations should be performed to assess the intra-amniotic environment. If oligohydramnios is observed enalapril should be discontinued unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Infants with histories of in utero exposure should be closely observed for hypotension, oliguria, and hyperkalemia.
Enalapril Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes Excreted into animal milk: Yes
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