Arava and Pregnancy

The FDA has classified Arava (leflunomide) as a pregnancy Category X medication, meaning it should not be used by women who are expecting. When given to pregnant animals, this drug caused miscarriages, blindness in the offspring, and other problems. It's also important to avoid this drug if you wish to become pregnant, due to how long it takes for the drug to be removed from the body.

Can Pregnant Women Take Arava?

Based on animal studies, Arava® (leflunomide) is considered unsafe for use in women who are pregnant or who may become pregnant. Arava has been given a pregnancy Category X classification based on its risks to the fetus.
 

What Is 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 have shown problems to the fetus in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the potential benefits.
 
Arava has not been studied in pregnant women, as it would be unethical to do so. However, when given to pregnant rats, even low doses of Arava caused problems, such as miscarriage and blindness in the rat offspring. It also caused abnormal development of the sternum when given to pregnant rabbits.
 
The use of a pregnancy Category X medicine during pregnancy is not recommended. Therefore, Arava should not be used in women who are pregnant or may become pregnant. If you are a woman of childbearing age, your healthcare provider will need to verify that you are not pregnant before you can begin taking this drug. It is also important for women to use a reliable form of birth control while taking Arava.
 
If you are taking Arava and want to become pregnant, talk to your healthcare provider. It can take up to two years for the drug to be completely removed from your body. However, your healthcare provider can give you a medicine called cholestyramine to help remove Arava from your body more quickly. Because of the risks associated with Arava use during pregnancy, it is important to wait until the drug has been completely eliminated from your body before trying to become pregnant.
 
If you suspect you may be pregnant, contact your healthcare provider right away. Arava should be removed from the body as soon as possible, ideally before your first missed period.
 
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