Is Atorvastatin 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 Atorvastatin. The text below is quoted from that source — it is not our own verdict.
Summary of 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 rosuvastatin and pravastatin.[1] Some evidence indicates that amounts of atorvastatin and its metabolites are milk are very low and it can be taken by nursing mothers with no obvious developmental problems in their infants. Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
Effects on the breastfed infant
In a case series of patients with homozygous familial hypercholesterolemia, 6 patients breastfed 11 infants after restarting statin therapy postpartum. The specific statin used by these women was not reported, most of the women on statin therapy were using atorvastatin, either 40 or 80 mg, daily. Normal early child development was reported for all offspring. Children started school at the appropriate age and no learning difficulties were reported.[3]
Two women who were taking atorvastatin in doses of 20 and 40 mg daily partially breastfed their infants. Mothers reported no infant adverse effects and no concerns about their development.[2]
Effects on milk supply
Gynecomastia has been reported in men taking atorvastatin.[4-6] Serum prolactin was normal in one case where it was measured.[6] In another case, possible rosuvastatin-induced gynecomastia resolved after the patient’s medication was changed to atorvastatin.[7]
Three women who were taking atorvastatin in doses of 20, 40 and 80 mg once daily donated milk samples at 0, 1, 2, 4, 6, 8, 10, 12, and 24 hours after their dose. Aliquots of complete milk collections were analyzed for cholesterol. Milk cholesterol levels were within previously established norms in the range of 10 mg/dL.[2]
Levels in milk
Maternal Levels. Three women who were taking atorvastatin in doses of 20, 40 and 80 mg once daily donated milk samples at 0, 1, 2, 4, 6, 8, 10, 12, and 24 hours after their dose. Aliquots of complete milk collections from both breasts were analyzed for atorvastatin and its active metabolites. The absolute infant dosages of atorvastatin was calculated at 0.066, 0.19, and 0.27 mcg/kg daily for the 20 mg, 40 mg, and 80 mg doses, respectively. The weight-adjusted relative infant dose of atorvastatin, 2-hydroxy- and 4-hydroxyatorvastatin was 0.05%, 0.09%, and 0.052% for atorvastatin doses of 20 mg, 40 mg, and 80 mg, respectively.[2]
Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
Atorvastatin in pregnancy
LactMed covers breastfeeding only. For what the NHS and the US prescribing label say about pregnancy, see:
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Atorvastatin” (LM485). 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.