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Ezetimibe / simvastatin Pregnancy and Breastfeeding Warnings

Ezetimibe / simvastatin is also known as: Vytorin

Medically reviewed by Drugs.com. Last updated on May 10, 2019.

Ezetimibe / simvastatin Pregnancy Warnings

Lipid lowering drugs offer no benefit during pregnancy. Cholesterol and cholesterol derivatives are needed for normal fetal development and HMG-CoA reductase inhibitors are known to inhibit these biosynthetic processes. Simvastatin studies in rats and rabbits have not shown teratogenicity at doses about 3 times the human exposure, however, studies with a structurally-related statin found skeletal malformations in rats and mice. In humans, there are rare reports of congenital anomalies following intrauterine exposure. Ezetimibe studies in rats and rabbits have not shown evidence of embryolethal effects; rats showed increased incidence of common fetal skeletal findings at about 10 times the estimated human exposure and rabbits showed an increased incidence of extra thoracic ribs at 150 times the human exposure. Multiple-dose studies of ezetimibe administered with statins in rats and rabbits during organogenesis have shown reproductive findings occurring at lower doses than if individual components were given alone. There are no controlled data in human 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 hypercholesterolemia.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use is contraindicated

AU TGA pregnancy category: D
US FDA pregnancy category: X

Comments:
-This drug is contraindicated in women who are or who may become pregnant; women of childbearing potential should be advised to use effective contraception.
-If pregnancy occurs, this drug should be immediately discontinued.

See references

Ezetimibe / simvastatin Breastfeeding Warnings

Use is contraindicated

Excreted into human milk: Unknown (ezetimibe); Unknown (simvastatin)
Excreted into animal milk: Yes (ezetimibe); Unknown (simvastatin)

Comments: The effects in the nursing infant are unknown.

There are no human or animal data specifically on the use of this combination drug during lactation. Rat studies have shown ezetimibe is excreted into breast milk, but it is not known if it is excreted into human milk. Simvastatin has not been reported in human or animal milk; although a small amount of another statin drug has been observed in human milk. Due to concerns with disrupting infant lipid metabolism, this drug should not be used during breastfeeding.

See references

References for pregnancy information

  1. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL: http://www.tga.gov.au/docs/pdf/medpreg.pdf." ([1999]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Vytorin (ezetimibe-simvastatin)." Merck & Company Inc, West Point, PA.

References for breastfeeding information

  1. "Product Information. Vytorin (ezetimibe-simvastatin)." Merck & Company Inc, West Point, PA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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