Trandolapril Pregnancy Warnings
Limited data have shown an association between major congenital malformations and the use of angiotensin-converting enzyme (ACE) inhibitors during the first trimester. 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 may result and is associated with fetal lung hypoplasia and skeletal deformations. There are no controlled data in human pregnancy.
Infants with in utero exposure to this drug should be closely monitored for hypotension, oliguria, and hyperkalemia. When pregnancy is detected or expected, this drug should be discontinued as soon as possible.
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.
AU: Use is contraindicated.
UK: Use is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters.
US: Use is not recommended.
AU TGA pregnancy category: D
US FDA pregnancy category: D
Comments: Adequate methods of contraception should be encouraged.
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