Enbrel and Pregnancy

The FDA has classified Enbrel as a pregnancy Category B medication, meaning that the medicine does not appear to cause harm to the fetus in animal studies. It is important to note, however, that animals do not always respond to medicines in the same way that humans do, and the full risks of taking Enbrel during pregnancy are not known. Therefore, be sure to talk to your healthcare provider about Enbrel and pregnancy.

 

Enbrel and Pregnancy: An Overview

For people who are pregnant, Enbrel® (etanercept) is generally considered safe. This is based on animal studies that looked at the effects of Enbrel during pregnancy.
 

Enbrel and Pregnancy Category B

The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category B is given to medicines that have not been studied in pregnant humans, but do not appear to cause harm to the fetus in animal studies.
 
It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category B medicine may be given to a pregnant woman only if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
 
There is a registry for pregnant women who take Enbrel during pregnancy. This registry collects information about pregnant women who took Enbrel during pregnancy, along with information about the health of their babies. In the future, this information will be used to determine if Enbrel is safe for pregnant women. Ask your healthcare provider if you would like to participate in the Enbrel pregnancy registry.
 

Recommendations for Enbrel and Pregnancy

If you are pregnant or thinking about becoming pregnant, let your healthcare provider know. Your healthcare provider will consider both the benefits and the risks of taking Enbrel during pregnancy before making a recommendation for your particular situation.
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;