Enalapril Pregnancy and Breastfeeding Warnings

Brand names: Epaned, Vasotec

Enalapril Pregnancy Warnings

Use should be avoided.
-According to some authorities: Use is contraindicated.
-According to some authorities: Use is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters.

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

Risk summary: Use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters of pregnancy can reduce fetal renal function and increase fetal/neonatal morbidity and death.

Comments:
-This drug can harm a developing fetus.
-According to some authorities, pregnancy should be excluded before starting treatment.
-Women of childbearing potential should consider use of effective contraception during treatment and up to 1 week after the last dose.
-Discuss other treatment options with women planning to become pregnant.
-If pregnancy is detected, discontinue this drug and advise patients to inform their physician immediately.
-If this drug is used during pregnancy, the patient should be apprised of the potential harm to the fetus.
-If ACE inhibitor exposure occurred during the second trimester of pregnancy, it is advised to perform an ultrasound check of renal function and skull.
-Monitor infants with a history of in utero exposure to this drug for hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occurs, institute appropriate medical measures to stabilize blood pressure and maintain renal perfusion; exchange transfusions or dialysis may be required.

Animal studies have revealed evidence of fetotoxicity. In humans, use of drugs that act on RAS during the second and third trimesters can cause reduced fetal renal function, leading to anuria and renal failure, oligohydramnios, fetal lung hypoplasia and skeletal deformations including skull hypoplasia, hypotension, and death. In a historical cohort study including over 29,000 infants, there was a 2.7 times higher risk of congenital malformations observed in infants exposed to ACE inhibitors during the first trimester compared to no exposure. 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 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 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 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.

See references

Enalapril Breastfeeding Warnings

Use is not recommended. A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
-According to some authorities: Use in preterm infants or during the first few weeks after delivery is not recommended unless necessary, and the infant should be monitored for adverse effects.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-This drug may cause severe adverse reactions in the breastfed infant, including hypotension, hyperkalemia, and renal impairment.
-Although this drug's concentration in breastmilk is low and the amount ingested by the infant is minimal, the potential adverse effects in the breastfed child should still be considered.

See references

Further information

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

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