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Simvastatin Pregnancy and Breastfeeding Warnings

Brand names: FloLipid, Zocor

Medically reviewed by Last updated on Jul 12, 2022.

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. 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. There are rare reports of congenital anomalies following intrauterine exposure. Two series of pregnant women who took an HMG-CoA reductase inhibitor (n=178 and n=134) during the first trimester of pregnancy, found serious fetal abnormalities in several cases including limb and neurological defects, spontaneous abortions, and fetal deaths. 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.

US 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

-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

Simvastatin Breastfeeding Warnings

It is not known if this drug is excreted in human milk; a small amount of another statin drug has been observed in human milk. In animal studies, reduced weight gain was observed in rat offspring dosed with 12.5 to 25 mg/kg/day. Due to concerns with disrupting infant lipid metabolism, most experts agree that this drug should not be used during breastfeeding.

Use is contraindicated

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Product Information. Zocor (simvastatin). Merck & Co., Inc. 2001;PROD.
  2. Cerner Multum, Inc. Australian Product Information.

References for breastfeeding information

  1. Product Information. Zocor (simvastatin). Merck & Co., Inc. 2001;PROD.
  2. Cerner Multum, Inc. Australian Product Information.
  3. United States National Library of Medicine. Toxnet. Toxicology Data Network. 2013.

Further information

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