Amlodipine and benazepril Pregnancy Warnings
Animal studies with amlodipine have revealed decreased litter size, increased intrauterine deaths, and prolonged gestation and labor. Animal studies with benazepril have failed to reveal evidence of teratogenicity. In humans, use of drugs that act on the renin angiotensin system during the second and third trimesters increases fetal and neonatal morbidity and death. There are no controlled data in human pregnancy.
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.
This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus.
US FDA pregnancy category: D
Comments: Adequate methods of contraception should be encouraged.
See references