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Fetal/Neonatal Morbidity and Mortality: Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women.
Valsartan must not be given to pregnant women or woman of child-bearing age with no intention to use contraception.
Pregnancy: Female patients of childbearing age should be told about the consequences of second and third trimester exposure to drug that act on the renin-angiotensin system and they should be told that these consequences do not appears to have resulted from intrauterine drug exposure that has been limited to the first trimester. These patients should be asked to report pregnancies to their physician as soon as possible.
