Is Pitavastatin safe while breastfeeding?

Summary of use during breastfeeding

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.

Effects on the breastfed infant

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 milk supply

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

Levels in milk

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.

Alternatives LactMed lists

• Cholestyramine
• Colesevelam
• Colestipol