Last update April 15, 2024

Pravastatin Sodium

Decreased level of risk

New scientific evidences have driven the Apilam staff to update the level of risk associated to this product.
Former level of risk, which was Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment., is now set to Safe. Compatible. Minimal risk for breastfeeding and infant.

Level of risk reviewed on April 10, 2024

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Hydrophilic statin (Pan 1991), which acts by reducing hepatic cholesterol synthesis. Indicated in the treatment of primary, hetero- and homozygous familial hypercholesterolemia (FH) and combined familial hyperlipemia. Authorized use from 8 years of age. Oral administration in a daily dose.

Its pharmacokinetic data (large volume of distribution, high molecular weight, acidic pKa, hydrophilicity, and rapid clearance) explain the null or negligible passage into breast milk observed. (Saito 2022, Pan 1988)

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

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

There are no published data to indicate that statins taken by the mother during breastfeeding are harmful to the nursing infant. (Holmsen 2017)

Mothers homozygous for FH took statins during 18 pregnancies and 11 breastfeedings of 3 to 9 months duration. The infants had no developmental or school learning problems. (Botha 2018)

Expert authors consider safe or probably compatible or of minimal risk the use of statins, especially the hydrophilic ones rosuvastatin or pravastatin, during pregnancy and/or breastfeeding. (Hale, 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 infants. (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 breastfeed 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 (FDA 2021, Shala 2020, Lawrence 2016 p 393). Except in severe forms of hypercholesterolemia (Moss 2018), postponing drug treatment for a few months is not likely to alter the long-term outcome of the disease in the mother. (FDA 2021)

One hundred and two women affected by FH stopped taking statins for a mean of 2.3 years (range 0 to 14 years) for the times of pregnancy and breastfeeding without it being known whether this increased the risk of cardiovascular disease (Klevmoen 2021). It is known that hypercholesterolemia maintained during pregnancy in a woman with FH increases the risk of atherosclerosis in the child (Napoli 1999), that these women develop very high cholesterol levels during this period (Holmsen 2017, Avis 2009) and that there is an increase in the thickness of the arterial intima media during pregnancy in women with FH. (Kusters 2010)

It is advisable to follow a lipid-lowering diet and exercise.

Cholesterol levels are normally increased (by 40%) during pregnancy and lactation in healthy women (Lawrence 2016 p590). Breast milk cholesterol is synthesized 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 & 767)

Cholesterol concentration is greatly increased (up to 3-fold) in the milk of lactating mothers affected with familial hypercholesterolemia in homozygous form (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 those fed artificial formulas and this would protect them against the consequences of hypercholesterolemia in adulthood. (Lawrence 2016 p108)

Infants fed formula substitutes ("artificial milks") 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 cholesterol reduction produced by the statins taken by the mother would still be much higher than that provided by artificial formulas(Holmsen 2017)

In conclusion, it seems wise to advise mothers with severe FH to continue statins during lactation. Mothers without FH and with moderately high cholesterol levels can discontinue statins during the lactation period by monitoring their low density lipoproteins (LDL) levels.

For considerations on the appropriateness of lipid-lowering treatment during lactation see Maternal hyperlipidemia, hypercholesterolemia, hypertriglyceridemia.


See below the information of this related product:

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

Pravastatin Sodium is also known as


Pravastatin Sodium in other languages or writings:

Group

Pravastatin Sodium belongs to this group or family:

Tradenames

Main tradenames from several countries containing Pravastatin Sodium in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 17 %
Molecular weight 447 daltons
Protein Binding 43 - 50 %
VD 0.5 l/Kg
pKa 4.21 -
Tmax 1 - 1.5 hours
1.5 -2 hours
Theoretical Dose 0.001 mg/Kg/d
Relative Dose 0.15 %

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. Saito J, Kaneko K, Abe S, Yakuwa N, Kawasaki H, Suzuki T, Yamatani A, Sago H, Murashima A. Pravastatin concentrations in maternal serum, umbilical cord serum, breast milk and neonatal serum during pregnancy and lactation: A case study. J Clin Pharm Ther. 2022 May;47(5):703-706. Consulted on May 31, 2022 Abstract
  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. 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)
  5. 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
  6. AEMPS-CINFA. Pravastatina. Ficha técnica. 2019 Full text (in our servers)
  7. 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)
  8. 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
  9. 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
  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. Sandoz. Pravastatin. Drug Summary. 2017 Full text (in our servers)
  12. Lawrence RA, Lawrence RM. Breastfeeding. A guide for the medical profession. Eighth Edition. Philadelphia: Elsevier; 2016
  13. 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)
  14. 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)
  15. 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)
  16. 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
  17. 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)
  18. 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
  19. Pan HY. Clinical pharmacology of pravastatin, a selective inhibitor of HMG-CoA reductase. Eur J Clin Pharmacol. 1991 Abstract
  20. 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)
  21. 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

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