Can I take valsartan while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Valsartan tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the 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 antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan (see Clinical Considerations) . When pregnancy is detected, consider alternative drug treatment and discontinue valsartan tablets as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Valsartan (oral), Lupin Pharmaceuticals, Inc. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Milk levels after the lowest dose of the combination of valsartan and sacubitril (Entresto) are very low. If the highest recommended maternal dosage (6 times greater) produces proportionate milk levels, they would likely still be quite low. Valsartan is unlikely to affect the nursing infant.

“Summary of Use during Lactation”, LactMed record “Valsartan” (LM730), quoted verbatim. Everything LactMed reports about Valsartan while breastfeeding.

8.2 Lactation Risk Summary There is no information regarding the presence of valsartan in human milk, the effects on the breastfed infant, or the effects on milk production. Valsartan is present in rat milk. Because of the potential for serious adverse reactions in breastfed infants from exposure to valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with valsartan tablets. Data: Valsartan was detected in the milk of lactating rats 15 minutes after oral administration of a 3 mg/kg dose.

Prescribing label, section “8.2 Lactation”: Valsartan (oral), Lupin Pharmaceuticals, Inc. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.