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Simvastatin Pregnancy and Breastfeeding Warnings

Simvastatin is also known as: FloLipid, Zocor

Medically reviewed on Oct 15, 2018

Simvastatin Pregnancy Warnings

While animal studies with simvastatin failed to reveal evidence of teratogenicity, animal studies with other HMG-CoA reductase inhibitors revealed an increase in the incidence of skeletal malformations. There are no controlled data in human pregnancy. However, HMG-CoA reductase inhibitors are known to inhibit biosynthetic processes necessary in fetal development.

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

Comments:
-Use of adequate methods of contraception should be encouraged.
-Serum cholesterol and triglycerides increase during normal pregnancy, and are essential for fetal development. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis, they cause fetal harm when administered to a pregnant woman. 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.

See references

Simvastatin Breastfeeding Warnings

-Animal studies have shown that weight gain during lactation is reduced in offspring of mothers dosed with simvastatin.
-Simvastatin should not be used during breastfeeding due to possible disruption of infant lipid metabolism.

Use is contraindicated.

Excreted into human milk: Unknown (a small amount of another drug in this class is excreted in human milk)

The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Zocor (simvastatin)." Merck & Co, Inc, West Point, PA.
  3. Mauro VF, MacDonald JL "Simvastatin: a review of its pharmacology and clinical use." DICP 25 (1991): 257-64

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Zocor (simvastatin)." Merck & Co, Inc, West Point, PA.
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  4. Mauro VF, MacDonald JL "Simvastatin: a review of its pharmacology and clinical use." DICP 25 (1991): 257-64

Further information

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

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