High cholesterol is usually not a concern for women who are in their childbearing years. However, some women do experience high cholesterol during pregnancy. Atorvastatin, also called Lipitor, is one of the more common medications prescribed to help manage high cholesterol. It is valid to question the safety of using atorvastatin during pregnancy. Its use during pregnancy is not recommended because of the potential adverse effects on your baby.
If you have been taking Lipitor, or atorvastatin, and recently discovered you are pregnant, it is important to consult your health care provider immediately.
Atorvastatin and Pregnancy
- Brand Name: Lipitor
- Manufacturer: Parke-Davis
Therapeutic Effect:
A multiple risk factor intervention, including lipid-altering agents, should be used in individuals with heightened risk for atherosclerotic vascular disease as a result of hypercholesterolemia.
When significant improvement has not been seen as a result of a dietary changes along with other non-pharacologic treatments, drug therapy may be used.
Pregnancy Recommendation: Atorvastatin is contraindicated in pregnancy.
Pregnancy Safety Rating: Category X
Side Effects to the Mother:
- Common: Atorvastatin is usually well tolerated. Side effects are generally mild and short-term.
- Frequent: (16%) Headache
- Occasional: (5%-2%) Pruritus, rash, myalgia, allergy
- Rare: (less than 2%-1%) Dyspepsia, flatulence, depression.
Pregnancy/Lactation Considerations: Atorvastatin is distributed in breast milk. It is contraindicated during pregnancy and may produce skeletal malformation.
Pregnancy Summaries:
The following summaries are cited directly from the sources of Briggs, Freeman, & Yaffe, the Physicians’ Desk Reference, and the Reprotox Toxicology Center.
Briggs, Freeman, & Yaffe – The interruption of cholesterol-lowering therapy during pregnancy should have no effect on long-term treatment of hyperlipidemia. Moreover, because cholesterol and products synthesized by cholesterol are important during fetal development, the use of atorvastatin is contraindicated during pregnancy.
However, the absolute embryo risk from inadvertent exposure in the 1st trimester appears to be low.
Physicians’ Desk Reference – Lipitor is contraindicated in women who are or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy. Lipid lowering drugs offer no benefit during pregnancy because cholesterol and cholesterol derivatives are needed for normal fetal development.
Atherosclerosis is a chronic process, and discontinuation or lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hypercholesterolemia therapy.
There are no adequate and well-controlled studies of atorvastatin use during pregnancy. There have been rare reports of congenital anomalies following intrauterine exposure to statins. In a review of about 100 prospectively followed pregnancies in women exposed to other statins, the incidences of congenital anomalies, spontaneous abortions, and fetal/stillbirths did not exceed the rate expected in the general population.
However, this study was only able to exclude a three-to-four increased risk of congenital anomalies over background incidence. In 89% of these cases, drug treatment started before pregnancy and stopped during the first trimester when pregnancy was identified. Atorvastatin crosses the rat placenta and reaches a level in fetal liver equivalent to that of maternal plasma.
Atorvastatin was not teratogenic in rats at doses up to 300 mg/kg/day or in rabbits at doses up to 100 mg/kg/day. These doses resulted in multiples of about 30 times (rat) or 20 times (rabbit) the human exposure based on surface area (mg/m2).
In a study in rats given 20, 100, or 225 mg/kg/day, from gestation day 7 through to lactation day 21 (weaning), there was decreased pup survival at birth, neonate, weaning, and maturity in pups of mothers dosed with 225 mg/kg/day. Body weight was decreased on days 4 and 21 in pups of mothers.
Reprotox Toxicology Center – Based on experimental animal studies and a small number of exposed human cases, inadvertent exposure to atorvastatin during early pregnancy appears unlikely to increase the risk of adverse pregnancy outcome.
Theoretical considerations concerning the role of cholesterol in embryo development plus the lack of demonstrated benefit of treating hyperlipidemia during gestation argue against intentional use of statins during pregnancy.
Next Steps:
If you are pregnant and have questions related to medication use during pregnancy, Reprotox Toxicology Center is the most comprehensive resource on medication use during pregnancy.
The American Pregnancy Association does not prescribe medication, nor do we serve as a consult for medication use during pregnancy. It is imperative that you discuss the use of any medication during pregnancy with your health care provider. The purpose of this document is to provide you with information to support discussions with your health care provider.
Sources:
Hudgson, Barbara and Kizior, Robert, Saunders Nursing Drug Handbook 2012, Elsevier, St. Louis, MO. ISBN: 978-1-4377-2334-2.
Briggs, Gerald, Freeman, Roger and Yaffe, Sumner, Drugs in Pregnancy and Lactation, 9th Ed., Wolters Kluwer/Lippincott Williams & 3. Wilkins, Philadelphia, PA. ISBN: 978-1-60831-708-0, 2011.
Physicians’ Desk Reference (PDR), PDR Network, LLC, Motvale, NJ 07645 ISBN: 978-1-56363-780-3
Reproductive Toxicology Center, https://www.reprotox.org, agent #4039
