Use in Pregnancy: Pregnancy Category X: Pitavastatin is contraindicated in women who are or may become pregnant. There are no adequate and well-controlled studies of pitavastatin in pregnant women, although, congenital abnormalities and/or skeletal malformations have occur in animals.
Lactation: It is not known whether pitavastatin is excreted in human milk, however, it has been shown that a small amount of another drug in this class passes into human milk. Rat studies have shown that pitavastatin is excreted into breast milk. Because another drug in this class passes into human milk and HMG-CoA reductase inhibitors have a potential to cause serious adverse reactions in nursing infants, pitavastatin is contraindicated during lactation.