Evista and Pregnancy

In animal studies on Evista and pregnancy, the drug caused a range of problems, from miscarriages and birth defects to delayed labor and delivery. As a result, the FDA assigned a pregnancy Category X rating to Evista -- this means it should never be taken by a pregnant woman. If you are taking Evista and pregnancy occurs, it's important that you tell your healthcare provider right away.

 

Evista and Pregnancy: An Overview

Evista® (raloxifene hydrochloride) is a prescription medication used to prevent and treat osteoporosis, as well as to prevent breast cancer. The drug should not be used during pregnancy or even in women who may become pregnant. It is important to remember that Evista is not approved for premenopausal women (including those who are pregnant).
 

Evista 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 is given to medicines that show problems to the fetus in animal studies or in humans who have taken the medicine.
 
Evista is a selective estrogen receptor modulator (SERM), which means that it sometimes acts like estrogen and sometimes acts like an anti-estrogen. Since disruption of estrogen can cause problems during pregnancy, it would be expected that Evista would not be safe for use during this time. When Evista was given to pregnant rabbits, it increased the risk of miscarriages, defects, and brain or skull problems. Giving the drug to pregnant rats caused developmental delays and problems, as well as delayed labor and delivery. In addition, the offspring of rats that were given Evista during pregnancy had reduced fertility as adults.
 

Evista and Pregnancy: Final Thoughts 

You should not take Evista if you are pregnant or may be pregnant. If you are pregnant or are thinking of becoming pregnant while taking the drug, let your healthcare provider know. If you become pregnant while taking Evista, tell your healthcare provider right away. You may need additional testing and monitoring to make sure that your pregnancy is progressing normally.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;