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Atorvastatin Pregnancy and Breastfeeding Warnings

Atorvastatin is also known as: Lipitor

Atorvastatin Pregnancy Warnings

Doses of 20, 100, or 225 mg/kg/day of atorvastatin from day 7 of gestation through day 21 of weaning resulted in decreased pup survival at birth, developmental delays, and pinnae detachment and eye opening alterations. Other HMG-CoA reductase inhibitors have been associated with increased fetal skeletal malformations. Additionally, the VATER association (vertebral anomalies, anal atresia, esophageal fistula with esophageal atresia, renal and radial dysplasia) was reported in an infant girl whose mother received lovastatin 10 mg daily and dextroamphetamine 10 mg daily during the first trimester of pregnancy for the treatment of hypercholesterolemia and progressive weight gain. Both drugs were discontinued five weeks later, at approximately 9 weeks gestation, when pregnancy was confirmed.

Atorvastatin has been assigned to pregnancy category X by the FDA. Animal studies have not revealed evidence of teratogenicity. However, other HMG-CoA reductase inhibitors have been associated with teratogenic effects. There are no controlled data in human pregnancy. Atorvastatin use is considered contraindicated in pregnancy.

See references

Atorvastatin Breastfeeding Warnings

There are no data on the excretion of atorvastatin into human milk; however, a small amount of another drug in this class does pass into breast milk. Briggs et. al. lists atorvastatin as contraindicated in nursing women. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, it is recommended that mothers discontinue nursing prior to initiation of therapy with atorvastatin.

Based on animal data, atorvastatin is likely to be excreted into human milk. Nursing animal pups of mothers administered atorvastatin had plasma and liver drug levels 50% and 40%, respectively, of that of their mother's milk. Animal breast milk drug levels may not accurately reflect human breast milk levels.

See references

References for pregnancy information

  1. "Product Information. Lipitor (atorvastatin)." Parke-Davis, Morris Plains, NJ.
  2. Ciaravino V, Kropko ML, Rothwell CE, Hovey CA, Theiss JC "The genotoxicity profile of atorvastatin, a new drug in the treatment of hypercholesterolemia." Mutat Res 343 (1995): 95-107
  3. Dostal LA, Schardein JL, Anderson JA "Developmental toxicity of the HMG-CoA reductase inhibitor, atorvastatin, in rats and rabbits." Teratology 50 (1994): 387-94

References for breastfeeding information

  1. "Product Information. Lipitor (atorvastatin)." Parke-Davis, Morris Plains, NJ.
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 7th ed." Philadelphia, PA: Lippincott Williams & Wilkins (2005):

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