Can I take atorvastatin while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Discontinue atorvastatin calcium tablets when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Atorvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, atorvastatin calcium may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology ( 12.1 )]. In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Atorvastatin Calcium (oral), QPharma, Inc. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

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.

“Summary of Use during Lactation”, LactMed record “Atorvastatin” (LM485), quoted verbatim. Everything LactMed reports about Atorvastatin while breastfeeding.

8.2 Lactation Risk Summary There is no information about the presence of atorvastatin in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. However, it has been shown that another drug in this class passes into human milk. Studies in rats have shown that atorvastatin and/or its metabolites are present in the breast milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk (see Data) . Statins, including atorvastatin, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant. Because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with atorvastatin calcium tablets [see Use in Specific Populations ( 8.1 ), Clinical Pharmacology ( 12.1 )] . Data Following a single oral administration of 10 mg/kg of radioactive atorvastatin to lactating rats, the concentration of total radioactivity was determined.

Prescribing label, section “8.2 Lactation” (opening excerpt): Atorvastatin Calcium (oral), QPharma, Inc. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.