Last update May 21, 2021

Simvastatin

Low Risk

Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

Fat-soluble statin, which acts by reducing cholesterol synthesis.
Indicated in the treatment of hypercholesterolemia, primary, familial (hetero and homozygous) and combined familial hyperlipidaemia.
Authorized use from 10 years of age.
Oral administration in a daily dose.

At the date of the last update, the authors did not find any published data on its excretion in breast milk.

Its pharmacokinetic data (very high percentage of protein binding and moderately high molecular weight) make it highly unlikely that significant quantities will pass into breast milk.

The tiny known secretion in breast milk, of pravastatin (Pan 1988) and rosuvastatin (Lwin 2018, Schutte 2013) and presumably from the rest of statins, is very unlikely to alter the lipid composition of breast milk and decrease its cholesterol concentration.

Because of its low oral bioavailability it has difficulty passing to the infant plasma from ingested breast milk, except in premature infants and in the immediate neonatal period in which there may be greater intestinal permeability.

Mothers homozygous for familial hypercholesterolemia took statins for 18 pregnancies and 11 lactations lasting 3 to 9 months. Infants had no developmental or school learning problems (Botha 2018).

Expert authors consider the use of statins, especially rosuvastatin or pravastatin, safe or probably compatible or of minimal risk during pregnancy and/or lactation (Hale 2021, Botha 2018, Holmsen 2017, Amir 2011).

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 hypercholesterolemia (Moss 2018), postponing drug treatment for a few months is unlikely to alter the long-term outcome of the disease in the mother. It is advisable to follow a lipid-lowering diet.

Cholesterol levels are normally increased (40%) during pregnancy and lactation in healthy women (Lawrence 2016 p590).
The cholesterol in breast milk is synthesized in the mammary gland and its concentration in breast milk ranges from 30 mg/dL in colostrum to 10 - 20 mg/dL in mature breast milk (Lawrence 2016 p98, 105 and 767).
The cholesterol concentration is greatly increased (up to 3 times higher) in the milk of lactating mothers with homozygous familial hypercholesterolemia (Holmsen 2017, Tsang 1978). Statin treatment would, at best, reduce it to normal levels (Holmsen 2017).

Cholesterol is necessary for the development of brain tissue, myelination of nerves, and is the basis for many enzymes. Breastfed infants have higher plasma cholesterol levels than those fed artificial formulas and this will protect them against the consequences of hypercholesterolemia in adult life (Lawrence 2016 p108).

Infants fed substitute formulas “artificial milk” do not receive cholesterol in their diet, as these products do not contain cholesterol (Lawrence 2016 p 109 and 215). The amount of cholesterol in breast milk that would remain after the hypothetical reduction in cholesterol produced by statins taken by the mother, would still be much higher than that provided by artificial formulas (Holmsen 2017).

Alternatives

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Simvastatin is also known as


Simvastatin in other languages or writings:

Group

Simvastatin belongs to this group or family:

Tradenames

Main tradenames from several countries containing Simvastatin in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. < 5 %
Molecular weight 419 daltons
Protein Binding > 95 %
pKa 14.91 -
Tmax 1 - 2 hours
1.9 - 4.8 hours

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 Full text (link to original source)
  2. FDA (U.S. Food and Drug Administration). Statins: drug safety communication - FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy. None 2021 Full text (link to original source)
  3. Klevmoen M, Bogsrud MP, Retterstøl K, Svilaas T, Vesterbekkmo EK, Hovland A, Berge C, Roeters van Lennep J, Holven KB. Loss of statin treatment years during pregnancy and breastfeeding periods in women with familial hypercholesterolemia. Atherosclerosis. 2021 Oct;335:8-15. Abstract Full text (link to original source)
  4. Shala-Haskaj P, Krähenmann F, Schmidt D. [CME: Familial Hypercholesterolemia - Statin Treatment during Pregnancy and Breastfeeding]. Praxis (Bern 1994). 2020 Apr;109(6):405-410. Abstract
  5. AEMPS-CINFA. Simvastatina. Ficha técnica. 2020 Full text (in our servers)
  6. Merk. Simvastatin. Drug Summary. 2019 Full text (in our servers)
  7. Botha TC, Pilcher GJ, Wolmarans K, Blom DJ, Raal FJ. Statins and other lipid-lowering therapy and pregnancy outcomes in homozygous familial hypercholesterolaemia: A retrospective review of 39 pregnancies. Atherosclerosis. 2018 Oct;277:502-507. Abstract
  8. Lwin EMP, Leggett C, Ritchie U, Gerber C, Song Y, Hague W, Turner S, Upton R, Garg S. Transfer of rosuvastatin into breast milk: liquid chromatography-mass spectrometry methodology and clinical recommendations. Drug Des Devel Ther. 2018 Oct 29;12:3645-3651. Abstract Full text (link to original source)
  9. Moss S, Tardo D, Doyle M, Rees D. Complex disease management of pregnant young patient with familial hypercholesterolaemia complicated by coronary artery disease and cerebrovascular disease. Cardiovasc Revasc Med. 2018 Dec;19(8S):20-22. Abstract
  10. Holmsen ST, Bakkebø T, Seferowicz M, Retterstøl K. Statins and breastfeeding in familial hypercholesterolaemia. Tidsskr Nor Laegeforen. 2017 May 23;137(10):686-687. Abstract Full text (link to original source)
  11. Lawrence RA, Lawrence RM. Breastfeeding. A guide for the medical profession. Eighth Edition. Philadelphia: Elsevier; 2016
  12. Schutte AE, Symington EA, du Preez JL. Rosuvastatin is transferred into human breast milk: a case report. Am J Med. 2013 Sep;126(9):e7-8. Abstract Full text (link to original source) Full text (in our servers)
  13. Amir LH, Pirotta MV, Raval M. Breastfeeding--evidence based guidelines for the use of medicines. Aust Fam Physician. 2011 Sep;40(9):684-90. Review. Abstract Full text (link to original source) Full text (in our servers)
  14. Kusters DM, Homsma SJ, Hutten BA, Twickler MT, Avis HJ, van der Post JA, Stroes ES. Dilemmas in treatment of women with familial hypercholesterolaemia during pregnancy. Neth J Med. 2010 Aug;68(1):299-303. Review. Abstract Full text (link to original source)
  15. Avis HJ, Hutten BA, Twickler MT, Kastelein JJ, van der Post JA, Stalenhoef AF, Vissers MN. Pregnancy in women suffering from familial hypercholesterolemia: a harmful period for both mother and newborn? Curr Opin Lipidol. 2009 Dec;20(6):484-90. Abstract
  16. Schachter M. Chemical, pharmacokinetic and pharmacodynamic properties of statins: an update. Fundam Clin Pharmacol. 2005 Abstract Full text (link to original source) Full text (in our servers)
  17. Napoli C, Glass CK, Witztum JL, Deutsch R, D'Armiento FP, Palinski W. Influence of maternal hypercholesterolaemia during pregnancy on progression of early atherosclerotic lesions in childhood: Fate of Early Lesions in Children (FELIC) study. Lancet. 1999 Oct 9;354(9186):1234-41. Abstract
  18. Mauro VF. Clinical pharmacokinetics and practical applications of simvastatin. Clin Pharmacokinet. 1993 Abstract
  19. Pan H, Fleiss P, Moore L, Glaess S, Ivashkiv E, Dollar D, Martynowicz H. Excretion of pravastatin, an HMG CoA reductase inhibitor, in breast milk of lactating women. In: Seventeeth Annual Meeting American College of Clinical Pharmacology, Abstracts. In: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006–. 2020 Feb 17. Abstract Full text (link to original source)
  20. Tsang RC, Glueck CJ, McLain C, Russell P, Joyce T, Bove K, Mellies M, Steiner PM. Pregnancy, parturition, and lactation in familial homozygous hypercholesterolemia. Metabolism. 1978 Jul;27(7):823-9. No abstract available. Abstract

Total visits

30,950

Help us improve this entry

How to cite this entry

Do you need more information or did not found what you were looking for?

   Write us at elactancia.org@gmail.com

e-lactancia is a resource recommended by El Parto Es Nuestro of Spain

Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM