Atorvastatin Calcium

Fat-soluble statin, which acts by reducing cholesterol synthesis. Indicated for the treatment of primary, familial (hetero- and homozygous) and combined familial hypercholesterolaemia. Authorised for use from the age of 10 years. Oral administration as a once-daily dose.

Pharmacokinetic data (large volume of distribution, high molecular weight, high percentage of protein binding, and acidic pKa) explain the minimal passage into breast milk observed. ^{(Campbell 2024)}

In three women treated with atorvastatin, milk cholesterol levels were within the normal range of 9 to 14 mg/dL, and two exposed infants had no problems. ^{(Campbell 2024).}

The very low secretion in breast milk, known for pravastatin (Pan 1988) and rosuvastatin (Lwin 2018, Schutte 2013) and presumed for all other statins, is very unlikely to alter the lipid composition of breast milk and lower its cholesterol concentration.

Its low oral bioavailability makes it difficult to pass into infant plasma from ingested breast milk, except in preterm infants and the immediate neonatal period where there may be increased intestinal permeability.

Mothers homozygous for familial hypercholesterolaemia took statins during 18 pregnancies and 11 breastfeedings of 3-9 months duration. The infants had no developmental or school learning problems. ^{(Botha 2018).}

Statin use, especially rosuvastatin or pravastatin, during pregnancy and/or breastfeeding is considered safe or probably compatible or of minimal risk by expert authors.  ^{(Hale 2021, Botha 2018, Holmsen 2017, Amir 2011)}

Breastfeeding has a cardioprotective effect, with reduced risk of myocardial infarction and hypertension, improved blood glucose control and lipid profile, and reduced risk of type 2 diabetes, which is particularly important for women with FH and their children. ^{(Holmsen 2017)}

The health benefits of a woman with FH continuing to breastfeed while using a statin outweigh the low risk to the child. It is safe and beneficial for children of women with FH to be breastfed while the mother is receiving adequate treatment with a statin, preferably rosuvastatin. ^{(Holmsen 2017)}

Other authors advise postponing statin treatment from 3 months before pregnancy and until breastfeeding ends or is not exclusive ^{(Shala 2020, Lawrence 2016 p 393)}. Except in severe forms of hypercholesterolaemia ^{(Moss 2018)}, postponing drug treatment for a few months is unlikely to alter the long-term outcome of the disease in the mother. A lipid-lowering diet should be followed.

Cholesterol levels are normally increased (by 40%) during pregnancy and lactation in healthy women ^{(Lawrence 2016 p590)}. Cholesterol in breast milk is synthesised in the mammary gland and its concentration in breast milk varies from 30 mg/dL in colostrum to 10 - 20 mg/dL in mature milk. ^{(Lawrence 2016 p98, 105 and 767).}

Cholesterol concentration is greatly increased (up to 3 times higher) in the milk of lactating mothers affected with homozygous familial hypercholesterolaemia ^{(Holmsen 2017, Tsang 1978)}. Statin treatment would at most reduce it to normal levels. ^{(Holmsen 2017)}

Cholesterol is necessary for the development of brain tissue, myelination of nerves and is the basis of many enzymes.

Breastfed infants have higher plasma cholesterol levels than formula-fed infants and this would protect them against the consequences of hypercholesterolaemia in adulthood ^{(Lawrence 2016 p108)}. Infants fed on commercial infant formula (‘artificial milks’) do not receive cholesterol in their diet, as these products do not contain cholesterol (0 - 0.4 mg/dL) ^{(Campbell 2024, Lawrence 2016 p 109 and 215)}. The amount of cholesterol in breast milk that would remain after the hypothetical cholesterol reduction produced by statins taken by the mother would still be much higher than that provided by artificial formulas. ^{(Holmsen 2017)}

See below the information of this related product:

• Maternal Hyperlipidemia, Hypercholesterolemia, Hypertriglyceridemia (Safe substance and/or breastfeeding is the best option.)