Valianz HCT Use In Pregnancy & Lactation

Women of child bearing potential: As for any drug that also acts directly on the RAAS, valsartan + hydrochloride should not be used in women planning to become pregnant. Healthcare professionals prescribing any agents on the RAAs should counsel women of childbearing about the potential risk of these agents during pregnancy.
Pregnancy: As for any that also acts directly on the RAAS, valsartan + hydrochlorothiazide must not be used during pregnancy. Due to mechanism of action of Angiotensin II antagonists, a risk for the fetus cannot be excluded. In utero exposure to angiotensin converting enzyme (ACE) inhibitors (a specifc class of drugs acting on the renin-angiotensin-aldosterone system-RAAS) given to pregnant women during the second and third trimester has been reported to cause injury and death to the developing fetus. 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 new born renal dysfunction, when pregnant women have inadvertently take valsartan.
Intrauterine exposure to thiazide diuretics, including hydrochlorothiazides, is associated with fetal or neonatal jaundice or thrombocytopenia, and may be associated with other adverse reactions that have occurred in adults.
Breastfeeding: It is not known whether valsartan is excreted in human milk. Valsartan was excreted in the milk of lactating rats. Hydrochlorothiazide crosses the placenta and is excreted in human milk. Thus, use is not advisable in breast-feeding mothers.
Fertility: There is no information on the effects of valsartan or hydrochlorothiazide on human fertility. Studies rats did not show any effects of valsartan or hydrochlorothiazide on fertility.