Fetal Risk

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nebivolol - valsartan (FDA-USA)

Nebivolol - Valsartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to angiotensin receptor blockers use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Studies in rats and rabbits with valsartan showed fetotoxicity only at maternally toxic doses. Embryofetal and perinatal lethality have been observed when nebivolol was given to pregnant rats during organogenesis at doses approximately equivalent to the MRHD. Published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan. When pregnancy is detected, discontinue Nebivolol - Valsartan as soon as possible.