Diovan Use In Pregnancy & Lactation

Pregnancy: Risk summary: As for any drug that also acts directly on the RAAS, Diovan must not be used during pregnancy (see CONTRAINDICATIONS). Due to the mechanism of action of angiotensin II antagonists, a risk for the fetus cannot be excluded. In utero exposure to ACE inhibitors (a specific class of drugs acting on the RAAS) during the second and third trimesters 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 newborn renal dysfunction, when pregnant women have inadvertently taken valsartan. If pregnancy is detected during therapy, Diovan should be discontinued as soon as possible (see ANIMAL DATA as follows).
Clinical considerations: Disease-associated maternal and/or embryo/fetal risk.
Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death.
Fetal/Neonatal Risk: Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death.
In case of accidental exposure to ARB therapy, appropriate fetal monitoring should be considered.
Infants whose mothers have taken ARB therapy should be closely observed for hypotension.
Animal data: In embryofetal development studies in mice, rats and rabbits, fetotoxicity was observed in association with maternal toxicity in rats at valsartan doses of 600 mg/kg/day approximately 6 times the maximum recommended human dose on a mg/m² basis (calculations assume an oral dose of 320 mg/day and a 60-kg patient) and in rabbits at doses of 10 mg/kg/day approximately 0.6 times the maximum recommended human dose on a mg/m² basis (calculations assume an oral dose of 320 mg/day and a 60-kg patient). There was no evidence of maternal toxicity or fetotoxicity in mice up to a dose level of 600 mg/kg/day approximately 9 times the maximum recommended human dose on a mg/m² basis (calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Breast-feeding: Risk summary: It is not known whether valsartan is excreted in human milk. Since valsartan was excreted in the milk of lactating rats, it is not advisable to use Diovan in breast-feeding mothers.
Females and males of reproductive potential: As for any drug that acts directly on the RAAS, Diovan should not be used 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.
Infertility: There is no information on the effects of Diovan on human fertility. Studies in rats did not show any effects of valsartan on fertility (see Pharmacology: Toxicology: NON-CLINICAL SAFETY DATA under Actions).