Frepan Use In Pregnancy & Lactation

Use during pregnancy: Due to the mechanism of action of angiotensin II antagonists, a risk for the foetus cannot be excluded. In utero exposure to ACE inhibitors (a specific class of medicinal products acting on the RAAS) during the second and third trimesters has been reported to cause injury and death to the developing foetus. In addition, in retrospective data, first trimester use of ACE inhibitors has been associated with a potential risk of birth defects. There have been reports of spontaneous abortion, oligohydramnios and newborn renal dysfunction, when pregnant women have inadvertently taken the angiotensin II antagonist valsartan. As for any medicinal product that also acts directly on the RAAS, candesartan cilexetil should not be used during pregnancy (see Contraindications) or in women planning to become pregnant. Healthcare professionals prescribing any agents acting on the RAAS should counsel women of childbearing potential about the potential risk of these agents during pregnancy. If pregnancy is detected during therapy, candesartan cilexetil should be discontinued as soon as possible.
Use during lactation: Because no information is available regarding the use of candesartan cilexetil during breast-feeding, candesartan cilexetil is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.