Attribution Statement: LactMed is a registered trademark of the U.S. Department of Health and Human Services.
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-.
CASRN: 81093-37-0
Drug Levels and Effects
Summary of Use during Lactation
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.
Drug Levels
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.
Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Alternate Drugs to Consider
References
- 1.
- Holmsen ST, Bakkebo T, Seferowicz M, et al. Statins and breastfeeding in familial hypercholesterolaemia. Tidsskr Nor Laegeforen 2017;137:686-7. [PubMed: 28551957]
- 2.
- Pan H, Fleiss P, Moore L, et al. Excretion of pravastatin, an HMG CoA reductase inhibitor, in breast milk of lactating women. J Clin Pharmacol 1988;28:942. doi:10.1002/j.1552-4604.1988.tb03114.x [CrossRef]
- 3.
- Saito J, Kaneko K, Abe S, et al. Pravastatin concentrations in maternal serum, umbilical cord serum, breast milk and neonatal serum during pregnancy and lactation: A case study. J Clin Pharm Ther 2022;47:703-6. [PubMed: 34951046]
Substance Identification
Substance Name
Pravastatin
CAS Registry Number
81093-37-0
Drug Class
Breast Feeding
Lactation
Milk, Human
Anticholesteremic Agents
Antilipemic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.
- User and Medical Advice Disclaimer
- Drugs and Lactation Database (LactMed) - Record Format
- LactMed - Database Creation and Peer Review Process
- Fact Sheet. Drugs and Lactation Database (LactMed)
- Drugs and Lactation Database (LactMed) - Glossary
- LactMed Selected References
- Drugs and Lactation Database (LactMed) - About Dietary Supplements
- Breastfeeding Links
- PubChem SubstanceRelated PubChem Substances
- PubMedLinks to PubMed
- Review Lovastatin.[Drugs and Lactation Database (...]Review Lovastatin.. Drugs and Lactation Database (LactMed®). 2006
- Review Rosuvastatin.[Drugs and Lactation Database (...]Review Rosuvastatin.. Drugs and Lactation Database (LactMed®). 2006
- Review Simvastatin.[Drugs and Lactation Database (...]Review Simvastatin.. Drugs and Lactation Database (LactMed®). 2006
- Review Fluvastatin.[Drugs and Lactation Database (...]Review Fluvastatin.. Drugs and Lactation Database (LactMed®). 2006
- Review Pitavastatin.[Drugs and Lactation Database (...]Review Pitavastatin.. Drugs and Lactation Database (LactMed®). 2006
- Pravastatin - Drugs and Lactation Database (LactMed®)Pravastatin - Drugs and Lactation Database (LactMed®)
Your browsing activity is empty.
Activity recording is turned off.
See more...