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Enalaprilat Pregnancy and Breastfeeding Warnings

Enalaprilat Pregnancy Warnings

Animal studies have revealed evidence of fetotoxicity. In humans, use of drugs that act on RAS during the second and third trimesters can cause the following: reduced fetal renal function leading to anuria and renal failure, oligohydramnios, fetal lung hypoplasia and skeletal deformations including skull hypoplasia, hypotension, and death. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US 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.

US 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.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use during pregnancy is considered contraindicated. (AU, UK)
This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk. (US)

AU TGA pregnancy category: D
US FDA pregnancy category:
-Oral tablets: D
-Injection solution: D (for use during the second and third trimesters) and C (during the first trimester)
-Oral solution: Not Assigned

Risk Summary: Use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity and death.

-Adequate methods of contraception should be encouraged.
-If pregnancy is detected, discontinue this drug as soon as possible.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

See references

Enalaprilat 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. (AU, US)
-According to the manufacturer, use during lactation is not recommended when the infant is preterm or in the first few weeks after delivery. Use of by mothers of older infants can be considered if the treatment is necessary for the mother and the infant is monitored for any adverse effects. (UK)

Excreted into human milk: Yes

See references

References for pregnancy information

  1. Schubiger G, Flury G, Nussberger J. Enalapril for pregnancy-induced hypertension: acute renal failure in a neonate. Ann Intern Med. 1988;108:215-6.
  2. Product Information. Vasotec (enalapril). Merck & Co., Inc. 2002.
  3. Thorpe-Beeston JG, Armar NA, Dancy M, Cochrane GW, Ryan G, Rodeck CH. Pregnancy and ACE inhibitors. Br J Obstet Gynaecol. 1993;100:692-3.
  4. Mehta N, Modi N. Ace inhibitors in pregnancy. Lancet. 1989;2:96.
  5. 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. 1990;162:187-9.
  6. Smith AM. Are Ace inhibitors safe in pregnancy? Lancet. 1989;2:750-1.
  7. 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. 1994;96:451-6.
  8. Reisenberger K, Egarter C, Sternberger B, Eckenberger P, Eberle E, Weissenbacher ER. Placental passage of angiotensin-converting enzyme inhibitors. Am J Obstet Gynecol. 1996;174:1450-5.
  9. Koren G, Pastuszak A, Ito S. Drugs in pregnancy. N Engl J Med. 1998;338:1128-37.
  10. Cooper WO, Hernandez-Diaz S, Arbogast PG, et al. Major congenital malformations after first-trimester exposure to ACE inhibitors. N Engl J Med. 2006;354:2443-51.
  11. Cerner Multum, Inc. Australian Product Information.

References for breastfeeding information

  1. Redman CW, Kelly JG, Cooper WD. The excretion of enalapril and enalaprilat in human breast milk. Eur J Clin Pharmacol. 1990;38:99.
  2. Rush JE, Snyder DL, Barrish A, Hichens M. Enalapril treatment of a nursing mother with slightly impaired renal function (response). Clin Nephrol. 1991;35:234.
  3. Product Information. Vasotec (enalapril). Merck & Co., Inc. 2002.
  4. the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT), Royal Australian College of General Practicioners (RACGP), the Pharmaceutical Society of Australia (PSA). Australian Medicines Handbook. 2007.
  5. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.