Is Pravastatin safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Pravastatin. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Levels of pravastatin in milk are low, but no relevant published information exists with its use during breastfeeding. The consensus opinion is that women taking a statin should not breastfeed because of a concern with disruption of infant lipid metabolism. 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 pravastatin and rosuvastatin.[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
Relevant published information was not found as of the revision date.
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. Eleven lactating women who were not breastfeeding were given 20 mg of pravastatin orally twice daily for 2.5 days. Serum and milk samples were taken at various times after the 5th dose and analyzed for pravastatin and its active metabolite. Peak milk levels averaged 3.9 mcg/L for pravastatin and 2.1 mcg/L for its metabolite. The authors suggested that negligible levels were excreted into breast milk, but that benefits and risks should be carefully considered.[2] Using the peak levels above, a fully breastfed infant would receive a maximum of 900 ng/kg daily with this dosage or about 0.13% of the maternal weight-adjusted dosage.
Two women were receiving oral pravastatin 10 mg daily during pregnancy. Two milk samples from each woman were obtained between 69.3 and 130 hours after their previous doses. Pravastatin was undetectable (<5 ng/L) in all the samples.[3]
Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
Pravastatin in pregnancy
LactMed covers breastfeeding only. For what the NHS and the US prescribing label say about pregnancy, see:
“No published information” means the studies do not exist yet — not that Pravastatin is known to be harmful, and not that it is known to be safe. Your prescriber or pharmacist can weigh your baby's age and whether a better-studied alternative would do the same job. Worth asking before stopping a medicine you need.
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Pravastatin” (LM481). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.