Perindopril Pregnancy and Breastfeeding Warnings

Perindopril is also known as: Aceon

Perindopril Pregnancy Warnings

FDA pregnancy category: D Use of perindopril is contraindicated (see Black Box Warning). Animal and human data have revealed evidence of embryolethality and teratogenicity associated with angiotensin converting enzyme (ACE) inhibitors. When pregnancy is detected, ACE inhibitors should be discontinued as soon as possible. If no alternative to ACE inhibitor therapy is available, patients should be made aware of the risks to their fetuses and the intra-amniotic environment should be evaluated by serial ultrasound examinations. Women of childbearing potential should be encouraged to use adequate contraception.

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. The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy have 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 renal function; oligohydramnios in this setting has been associated with decreased fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Exposure to ACE inhibitors during the first trimester of pregnancy has been associated with prematurity, intrauterine growth retardation, patent ductus arteriosus, other structural cardiac malformations, and neurological malformations. Mothers whose embryos and fetuses are exposed to an ACE inhibitor should be informed of the risks. When pregnancy is detected or expected, perindopril should be discontinued as soon as possible. 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.

Perindopril Breastfeeding Warnings

Potential benefit should outweigh the potential risk. Excreted into human milk: Unknown. Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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