Pitavastatin Pregnancy and Breastfeeding Warnings
Pitavastatin is also known as: Livalo
Pitavastatin Pregnancy Warnings
Pitavastatin has been assigned to pregnancy category X by the FDA. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol products are essential for fetal development. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hyperlipidemia therapy. Animal studies have not revealed evidence of teratogenicity. However, other HMG-CoA reductase inhibitors have been associated with teratogenic effects. There are no controlled data in human pregnancy. Pitavastatin is contraindicated in women who are or may become pregnant.
There are no adequate and well-controlled studies of pitavastatin in pregnant women. There have been rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors. In a review of about 100 pregnancies in women exposed to other HMG-CoA reductase inhibitors, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed the rate expected in the general population. However, this study was only able to exclude a 3-to-4-fold increased risk of congenital anomalies over background incidence. In 89% of these cases, drug treatment started before pregnancy and stopped during the first trimester when pregnancy was identified.
Pitavastatin Breastfeeding Warnings
There are no data on the excretion of pitavastatin into human milk, but a small amount of another drug in this class does pass into human breast milk. Because another drug in this class passes into human milk and because HMG-CoA reductase inhibitors have a potential to cause serious adverse reactions in nursing infants, the manufacturer recommends that women who require pitavastatin treatment should be advised not to nurse their infants.
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