Pitavastatin and Breastfeeding

Summary of use during lactation

No published information exists on the use of pitavastatin during breastfeeding. It is 99% bound to plasma proteins, so amounts in milk are likely low. Because of a concern with disruption of infant lipid metabolism, the consensus is that pitavastatin should not be used during breastfeeding. However, others have argued that children homozygous for familial hypercholesterolemia are treated with statins beginning at 1 year of age, that statins have low oral bioavailability, and risks to the breastfed infant are low, especially with rosuvastatin and pravastatin.[1] Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Drug levels in milk and infant serum

Maternal Levels. Relevant published information was not found as of the revision date. Infant Levels. Relevant published information was not found as of the revision date.

Effects in breastfed infants

A woman with peripartum cardiomyopathy and severe nonsustained ventricular tachycardia gave birth to twins. Pitavastatin 2 mg daily as well as amiodarone, bisoprolol, edoxaban, febuxostat, imidapril, and vonoprazan were started postpartum. Breastfeeding began 39 days after birth when the daily intake of breastmilk was 160 mL for the first infant and 120 mL for the second, smaller infant. Breastmilk was mixed with infant formula and accounted for approximately one-quarter of their total daily milk intake. The mother breastfed in infants for approximately two months after starting breastfeeding and the infants had no bleeding tendency. At 3 years of age, both infants had a tendency toward obesity, but no other complications or developmental delay.[2]

Effects on lactation and breastmilk

Relevant published information was not found as of the revision date.

Alternative drugs to consider

Cholestyramine, Colesevelam, Colestipol

References

1. Holmsen ST, Bakkebo T, Seferowicz M, et al. Statins and breastfeeding in familial hypercholesterolaemia. Tidsskr Nor Laegeforen 2017;137:686–7.28551957 PubMed
2. Watanabe C, Wachi T, Kamada S, et al. Measurement of amiodarone levels in the breast milk of a Japanese woman with peripartum cardiomyopathy. Cureus 2025;17:e89301.40909045 PubMed