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Pitavastatin Pregnancy and Breastfeeding Warnings

Pitavastatin is also known as: Livalo, Nikita, Zypitamag

Medically reviewed on Apr 9, 2018

Pitavastatin Pregnancy Warnings

Use in women who are or may become pregnant is contraindicated.

US FDA pregnancy category: X

-If the patient becomes pregnant while taking this drug, therapy should be discontinued and the patient should be apprised of the potential harm to the fetus.
-Use of adequate methods of contraception should be encouraged.

Animal studies have revealed evidence of reduced body weight, abortion, decreased survival of neonates, and mortality at doses that also produced maternal toxicity. Rare cases of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been reported. There are no controlled data in human pregnancy.

Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol products are essential for fetal development. Since atherosclerosis is a chronic process, discontinuation of lipid-lowering drugs during pregnancy should have little impact on long term outcomes of primary hyperlipidemia therapy.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

See references

Pitavastatin Breastfeeding Warnings

Use is contraindicated.

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

-A similar drug of this class has been detected in small amounts in human milk.
-This drug should not be used during breastfeeding due to the potential for serious adverse events in nursing infants and the concern over disruption of infant lipid metabolism.

See references

References for pregnancy information

  1. "Product Information. Livalo (pitavastatin)." Kowa Pharmaceuticals America (formerly ProEthic), Montgomery, AL.

References for breastfeeding information

  1. "Product Information. Livalo (pitavastatin)." Kowa Pharmaceuticals America (formerly ProEthic), Montgomery, AL.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

Further information

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