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).

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 Also...

• Rosuvastatin use while Breastfeeding (in more detail)
• rosuvastatin Consumer Information
• Pregnancy Support Group
• FDA Pregnancy Categories
• Medicine use during Pregnancy
• Medicine use while Breastfeeding
• Safe Medications during Breastfeeding

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This drug information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information in contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.