Summary of Use during Lactation

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 atorvastatin 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.

Drug Levels

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

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.[2]

Effects on Lactation and Breastmilk

Gynecomastia has been reported in men taking atorvastatin.[3-5] Serum prolactin was normal in one case where it was measured.[5] In another case, possible rosuvastatin-induced gynecomastia resolved after the patient’s medication was changed to atorvastatin.[6]

Alternate 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. [PubMed: 28551957]

2.

Botha TC, Pilcher GJ, Wolmarans K, et al. Statins and other lipid-lowering therapy and pregnancy outcomes in homozygous familial hypercholesterolaemia: A retrospective review of 39 pregnancies. Atherosclerosis. 2018;277:502–7. [PubMed: 30270091]

3.

Hammons KB, Edwards RF, Rice WY. Golf-inhibiting gynecomastia associated with atorvastatin therapy. Pharmacotherapy. 2006;26:1165–8. [PubMed: 16863492]

4.

Bostanitis I, Tsalidou M. Atorvastatin-induced gynecomastia in a dyslipidemic patient: A case report. Hellenic J Cardiol. 2019;60:194–5. [PubMed: 30145234]

5.

Famularo G, Sarrecchia C. Atorvastatin-associated gynecomastia. Ann Pharmacother. 2021;55:1300–1. [PubMed: 33472378]

6.

Oteri A, Catania MA, Travaglini R, et al. Gynecomastia possibly induced by rosuvastatin. Pharmacotherapy. 2008;28:549–51. [PubMed: 18363539]

Substance Name

Atorvastatin

CAS Registry Number

110862-48-1

Drug Class

Breast Feeding

Lactation

Anticholesteremic Agents

Antilipemic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors