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Rosuvastatin Pregnancy and Breastfeeding Warnings

Rosuvastatin is also known as: Crestor

Rosuvastatin Pregnancy Warnings

Rosuvastatin has been assigned to pregnancy category X by the FDA. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol products are essential for fetal development. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hyperlipidemia therapy. 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. Rosuvastatin is contraindicated in women who are or may become pregnant.

Rosuvastatin oral gavage doses of 5, 15, 50 mg/kg/day given to female rats before mating and continuing through day 7 postcoitus result in decreased fetal body weight (female pups) and delayed ossification at the high dose (systemic exposures 10 times human exposure at 40 mg/day based on AUC comparisons).

See references

Rosuvastatin Breastfeeding Warnings

There are no data on the excretion of rosuvastatin into human milk, but a small amount of another drug in this class does pass into human breast milk. Because another drug in this class passes into human milk and because HMG-CoA reductase inhibitors have a potential to cause serious adverse reactions in nursing infants, the manufacturer recommends that women who require rosuvastatin treatment should be advised not to nurse their infants.

See references

References for pregnancy information

  1. "Product Information. Crestor (rosuvastatin)." AstraZeneca Pharma Inc, Mississauga, ON.

References for breastfeeding information

  1. "Product Information. Crestor (rosuvastatin)." AstraZeneca Pharma Inc, Mississauga, ON.

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