Valgen-AM Use In Pregnancy & Lactation

Pregnancy: Risk Summary: As for any drug that acts directly on the renin-angiotensin-aldosterone system (RAAS), VALGEN-AM must not be used during pregnancy. Due to the mechanism of action of angiotensin II antagonists, a risk to the foetus cannot be excluded.
Administration of angiotensin converting enzyme (ACE) inhibitors (a specific class of drugs acting on the renin-angiotensin-aldosterone system (RAAS)) to pregnant women 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 new born renal dysfunction when pregnant women have inadvertently taken valsartan.
There are no adequate clinical data with amlodipine in pregnant women. Animal studies with amlodipine have shown reproductive toxicity at dose 8 times the maximum recommended dose of 10 mg. The potential risk to humans is unknown. If pregnancy is detected during therapy, VALGEN-AM must be discontinued as soon as possible.
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 in the first trimester should be closely observed for hypotension.
Lactation: It is not known whether valsartan is excreted in human milk. It is reported that amlodipine is excreted in human milk. The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3-7%, with a maximum of 15%. The effect of amlodipine on infants is unknown. Valsartan was excreted in the milk of lactating rats. It is therefore not advisable for women who are breast-feeding to use VALGEN-AM.
Females and males of reproductive potential: As for any drug that acts directly on the renin-angiotensin-aldosterone system (RAAS), VALGEN-AM must not be used in women planning to become pregnant. Healthcare professionals prescribing any agents acting on the renin-angiotensin-aldosterone system (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 amlodipine or valsartan on human fertility. Studies in rats did not show any effects of amlodipine or valsartan on fertility.