Caduet and Pregnancy

Although no studies have been done on Caduet and pregnancy, because the drug contains atorvastatin, it was given a pregnancy Category X rating by the FDA. Statin medications (including atorvastatin) have caused birth defects or other problems for the fetus. Because the risk to the fetus is likely greater than the benefits to the woman, if you are taking Caduet and pregnancy occurs, tell your healthcare provider right away.

 

Caduet and Pregnancy: An Overview

Caduet® (amlodipine and atorvastatin) is a pregnancy Category X medicine, meaning that it could potentially cause harm to your unborn child. Therefore, women who are pregnant should not take Caduet. If you are pregnant or are thinking about becoming pregnant while taking the drug, talk to your healthcare provider immediately.
 

Caduet and Pregnancy Category X

The U.
 S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category X refers to medicines that cause problems in the fetus in pregnant animal studies or in humans who have mistakenly taken the drug while pregnant. The use of a Category X medicine during pregnancy is not recommended.
 
Caduet is a combination medication, containing amlodipine (Norvasc®) and atorvastatin (Lipitor®). It was given a pregnancy Category X rating due to the atorvastatin component. Atorvastatin is a "statin" medication. There is some evidence that statins can cause birth defects or other problems when used during pregnancy.
 
Statins are used to treat high cholesterol, and the effects of high cholesterol do not normally cause problems for many years (or even decades). Therefore, if a woman does not take cholesterol medicine during pregnancy, it is likely to have very little or no impact on her long-term health. Since there is little benefit to taking atorvastatin while pregnant and there is a very real risk to the fetus, your healthcare provider will most likely recommend that you not take Caduet while pregnant. If you are thinking of becoming pregnant while taking the drug, be sure to discuss this with your healthcare provider.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;