Trandolapril and verapamil Pregnancy Warnings
Animal studies with trandolapril have failed to reveal evidence of teratogenicity. Animal studies with verapamil have revealed evidence of embryolethality at doses that produced maternal toxicity. In humans, use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity and death. Verapamil may inhibit contractions if used at the end of pregnancy. 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.
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: This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: D
US FDA pregnancy category: D
Comments:
-Adequate methods of contraception should be encouraged.
-Female patients of childbearing age should be told about the consequences of exposure to this drug during pregnancy. Patients should be asked to report pregnancies as soon as possible.
See references
