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Atorvastatin Pregnancy and Breastfeeding Warnings

Atorvastatin is also known as: Lipitor

Atorvastatin Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity, however, doses of 20, 100, or 225 mg/kg/day given to rats from day 7 of gestation through day 21 of weaning resulted in decreased pup survival at birth, developmental delays, pinnae detachment, and eye opening alterations. Rare cases of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been reported. There are no controlled data in human pregnancy.

Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol products are essential for fetal development. Since atherosclerosis is a chronic process, discontinuation of lipid-lowering drugs during pregnancy should have little impact on long term outcomes of primary hypercholesterolemia therapy.

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 in women who are or may become pregnant is contraindicated.

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

Comments:
-This drug should only be used in women of childbearing potential who are highly unlikely to conceive and have been informed of the potential hazards.
-If the patient becomes pregnant while taking this drug, therapy should be discontinued and the patient should be apprised of the potential harm to the fetus.
-Use of adequate methods of contraception should be encouraged.

See references

Atorvastatin Breastfeeding Warnings

Use is contraindicated.

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

Comments:
-A similar drug of this class has been detected in human milk.
-This drug should not be used during breastfeeding due to the potential for serious adverse events in nursing infants and the concern over disruption of infant lipid metabolism.

See references

References for pregnancy information

  1. "Product Information. Lipitor (atorvastatin)." Parke-Davis, Morris Plains, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Lipitor (atorvastatin)." Parke-Davis, Morris Plains, NJ.
  4. 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 -]):

Further information

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

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