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Nebivolol / valsartan Pregnancy and Breastfeeding Warnings

Nebivolol / valsartan is also known as: Byvalson

Medically reviewed on December 2, 2016

Nebivolol / valsartan Pregnancy Warnings

Hypertension in pregnancy increases the maternal risk for preeclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, postpartum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed.

Nebivolol: Beta blockers can cause hypotension, bradycardia, hypoglycemia, and respiratory depression in neonates.

Valsartan: Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations (i.e., skull hypoplasia, hypotension), and death.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not Assigned

Comments:
-This drug can cause fetal harm when administered to a pregnant woman.
-When pregnancy is detected, this drug should be discontinued as soon as possible.

Risk Summary: No reproductive animal toxicity studies have been conducted with the combination of nebivolol and valsartan.
-Nebivolol: When used during the second and third trimesters of pregnancy, drugs that act on the renin-angiotensin system can reduce fetal renal function and increase fetal and neonatal morbidity and death.
-Valsartan: No teratogenic effects were observed in animal studies; however, significant decreases in fetal weight, pup birth weight, pup survival rate, and slight delays in developmental milestones were observed during organogenesis or late gestation.

See references

Nebivolol / valsartan Breastfeeding Warnings

Because no information is available on the use of this drug during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Use should be avoided.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: Because of the potential for beta blockers to cause bradycardia and to affect postnatal renal development in nursing infants, women should be advised not to breastfeed during therapy.

See references

References for pregnancy information

  1. "Product Information. Byvalson (nebivolol-valsartan)." Actavis Pharma, Inc., Parsippany, NJ.

References for breastfeeding information

  1. "Product Information. Byvalson (nebivolol-valsartan)." Actavis Pharma, Inc., Parsippany, NJ.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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