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Enalapril / felodipine Pregnancy and Breastfeeding Warnings

Enalapril / felodipine is also known as: Lexxel

Enalapril / felodipine Pregnancy Warnings

Enalapril-felodipine 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, enalapril-felodipine should be discontinued as soon as possible. Enalapril-felodipine 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-felodipine 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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Enalapril / felodipine Breastfeeding Warnings

Enalapril and enalaprilat, the active metabolite, are excreted into human milk in small amounts. It is not known whether felodipine is excreted into human milk. Because of the potential for serious adverse reactions from enalapril and felodipine in nursing infants, a decision should be made either to discontinue the drug, taking into account the importance of the drug to the mother.

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References for pregnancy information

  1. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
  2. Kreft-Jais C, Plouin PF, Tchobroutsky C "Angiotensin-converting enzyme inhibitors during pregnancy: a survey of 22 patients given captopril and nine given enalapril." Br J Obstet Gynaecol 95 (1988): 420-2
  3. Cooper WO, Hernandez-Diaz S, Arbogast PG, et al "Major congenital malformations after first-trimester exposure to ACE inhibitors." N Engl J Med 354 (2006): 2443-51
  4. Smith AM "Are Ace inhibitors safe in pregnancy?" Lancet 2 (1989): 750-1
  5. Schubiger G, Flury G, Nussberger J "Enalapril for pregnancy-induced hypertension: acute renal failure in a neonate." Ann Intern Med 108 (1988): 215-6
  6. Shotan A, Widerhorn J, Hurst A, Elkayam U "Risks of angiotensin-converting enzyme inhibition during pregnancy: experimental and clinical evidence, potential mechanisms, and recommendations for use." Am J Med 96 (1994): 451-6
  7. Mehta N, Modi N "Ace inhibitors in pregnancy." Lancet 2 (1989): 96
  8. Thorpe-Beeston JG, Armar NA, Dancy M, Cochrane GW, Ryan G, Rodeck CH "Pregnancy and ACE inhibitors." Br J Obstet Gynaecol 100 (1993): 692-3
  9. Cunniff C, Jones KL, Phiullipson J, Benirschke K, Short S, Wujek J "Oligohydramnios sequence and renal tubular malformation associated with maternal enalapril use." Am J Obstet Gynecol 162 (1990): 187-9
  10. "Product Information. Lexxel (enalapril-felodipine)." Astra Pharmaceuticals, Wayne, PA.

References for breastfeeding information

  1. "Product Information. Lexxel (enalapril-felodipine)." Astra Pharmaceuticals, Wayne, PA.

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