Diltiazem / enalapril Pregnancy and Breastfeeding Warnings

Brand names: Teczem

Diltiazem / enalapril Pregnancy Warnings

Diltiazem-enalapril 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 ACE inhibitors. 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, diltiazem-enalapril should be discontinued as soon as possible. Diltiazem-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, diltiazem-enalapril should be discontinued as soon as possible.

A 30-year-old woman G3P2 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.

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Diltiazem / enalapril Breastfeeding Warnings

Enalapril and enalaprilat, the active metabolite, are excreted into human milk in amounts so small, adverse effects on nursing infants are considered unlikely. However, diltiazem is excreted into human milk in concentrations similar to maternal serum concentrations. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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Further information

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