Aubagio and Pregnancy
A pregnancy Category X medicine, Aubagio (teriflunomide) is considered dangerous to use during pregnancy, as it could potentially harm an unborn child. This drug may increase the risk for miscarriages and birth defects, among other complications.
Aubagio® (teriflunomide) is a prescription multiple sclerosis (MS) medication. Based on animal studies, this medication can be dangerous to an unborn child, and should not be taken by women who are pregnant or may become pregnant.
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. Aubagio is classified as a pregnancy Category X medication.
Pregnancy Category X is given to medicines that show 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.
In animal studies, Aubagio increased the risk for birth defects when given to pregnant rats or rabbits, including defects of the eyes, skin, skull, face, and bones. It also increased the risk for miscarriage. Because it would be unethical to give Aubagio to pregnant women, the drug has not been studied in pregnant women and is not likely to be studied in pregnant women.
Aubagio should not be used in women who are pregnant or women of childbearing potential who are not using a reliable form of birth control. If you are a woman of childbearing age, you will need to have a pregnancy test to ensure you are not pregnant before beginning Aubagio treatment.
During treatment, it is very important to use an effective form of birth control. You can talk to your healthcare provider about the best birth control options for your particular situation.
If you take Aubagio and wish to become pregnant, talk to your healthcare provider about how long you should wait after your last Aubagio dose and trying to conceive. It can take up to two years for Aubagio to be completely removed from your bloodstream. However, your healthcare provider can give you a medicine called cholestyramine (Prevalite®, Questran®, Questran® Light) to remove the drug from your body more quickly.
Because of the risks associated with Aubagio use during pregnancy, it is important to wait until Aubagio 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. Aubagio should be removed from the body as soon as possible.