Can you take Enbrel while pregnant?

In this article:

• Can you take Enbrel while pregnant?
• What are the risks of taking Enbrel while pregnant?
• Can you take Enbrel while breastfeeding?
• What can I take instead of Enbrel during pregnancy?

In this article

• Can you take Enbrel while pregnant?
• What are the risks of taking Enbrel while pregnant?
• Can you take Enbrel while breastfeeding?
• What can I take instead of Enbrel during pregnancy?

Enbrel (etanercept) is an injectable medication used to treat a variety of autoimmune and inflammatory conditions. It is approved by the Food and Drug Administration (FDA) to treat plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis. 

Enbrel is a biologic drug classified as a tumor necrosis factor (TNF) blocker. Biologics like these suppress the immune system by blocking specific inflammatory responses, according to the American College of Rheumatology. So, is Enbrel safe during pregnancy? The answer is complex. Keep reading to find out whether it is safe to take Enbrel while pregnant and why it’s essential to seek medical advice from a healthcare provider.

Can you take Enbrel while pregnant?

There is no one-size-fits-all answer to whether a person should take Enbrel while pregnant. The FDA classifies drugs used in pregnancy into one of five categories: A, B, C, D, and X. Drugs in category A are safest, while drugs categorized as X are unsafe. Enbrel is classified as category B, meaning either:

• Animal studies have revealed no evidence of harm to the fetus; however, there are no adequate and well-controlled studies in pregnant women; or

• Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus.

“The majority of studies looking at etanercept use during pregnancy have not shown an increased chance for a pattern of birth defects,” says Sarah Bechay, DO, an obstetrics and gynecology provider at Summit Health in New Providence, New Jersey. “The American College of Obstetrics & Gynecology (ACOG) categorizes TNF inhibitors as low-risk emerging therapies with developing evidence for use in pregnancy.”

Indeed, a recent systematic review of biologics for psoriasis during pregnancy determined that the drugs were not associated with an increased risk of miscarriage or fetal abnormalities. There’s no pattern of low birth weight, toxicity to the fetus, or other serious side effects that would harm the fetus.

Still, a category B drug isn’t considered risk-free. “Enbrel should not be used in pregnancy unless the benefits outweigh the risk,” says Kecia Gaither, MD, double board-certified OB-GYN and the director of perinatal and maternal-fetal medicine at NYC Health + Hospitals/Lincoln in the Bronx, New York. Healthcare providers who prescribe Enbrel to pregnant women have determined that the benefit the drug provides to the mother outweighs the potential risk of harm to the fetus. 

Ultimately, quality research on this Enbrel use in pregnant and lactating women is “very limited,” according to Dr. Bechay. Deciding whether to use this drug during pregnancy should be a shared decision after an in-depth discussion between a patient and their healthcare provider.

What are the risks of taking Enbrel while pregnant?

“There are no known risks to the mother when taking Enbrel while pregnant,” Dr. Bechay says. However, while there has been “no relationship found” between preterm birth and maternal Enbrel use, there is simply not enough data to say Enbrel use is definitely safe or unsafe for fetal development. 

This drug does cross the placenta, according to Dr. Gaither. However, as is the case with many medications taken during pregnancy, the risk of Enbrel crossing into the placenta is higher during the second and third trimesters than during the first trimester, according to Dr. Bechay. 

Still, just because a drug crosses the placenta does not automatically mean it causes fetal harm. Remember, the minimal data on Enbrel use during pregnancy has not shown that this exposure increases the risk of preterm labor or fetal abnormalities.

Both doctors emphasize how important it is to discuss risks versus benefits with your own healthcare provider. Managing an autoimmune condition while pregnant can be challenging. The benefits of Enbrel to pregnant women with psoriasis or rheumatoid arthritis are clear. Potential risks for the fetus are less clear. 

Can you take Enbrel while breastfeeding?

Healthcare providers cannot offer definitive medical guidelines, though the current FDA label for Enbrel states there has been no data on whether etanercept affects human milk production and no pattern of adverse events in breastfed infants. “Some healthcare providers believe that this makes the drug low-risk enough to be prescribed to nursing mothers,” says Dr. Bechay.

Although both doctors say there is evidence that Enbrel is “minimally excreted” into breast milk, Dr. Bechay adds that the small amount that travels into breast milk would not be easily absorbed by your baby. Remember, Enbrel is an injectable medication—it is not formulated to be metabolized within the digestive tract.

Ultimately, Enbrel use while breastfeeding should be a shared decision between a patient and healthcare provider after a thorough risk-versus-benefit discussion.

What can I take instead of Enbrel during pregnancy?

Common Enbrel alternatives for autoimmune diseases like rheumatoid arthritis include Otrexup (methotrexate), Orencia (abatacept), Actemra (tocilizumab), Rituxan (rituximab), and Xeljanz (tofacitinib). However, these aren’t necessarily safe alternatives during pregnancy. 

For example:

• Methotrexate is contraindicated for pregnant women because it can harm or kill a fetus. 
• Like Enbrel, Orencia lacks studies to verify safety during pregnancy, according to the National Institutes of Health (NIH).
• Actemra also lacks the data to definitely confirm safety. According to the NIH, some studies indicate that Actemra may raise the risk of miscarriage, but more research is needed.
• Rituxan is not recommended for pregnant women as research has linked it to low B cells in newborns. 
• Xeljanz also lacks sufficient research to know if it may cause pregnancy-related problems, according to the NIH.

So, what can you take instead of Enbrel? Depending on the condition Enbrel is treating, Dr. Bechary says there are others healthcare providers might consider, such as Plaquenil (hydroxychloroquine), which is sometimes used to treat rheumatoid arthritis and lupus.

However, Dr. Bechary warns that these alternatives may be less effective. Ultimately, any alternatives to Enbrel while pregnant should be chosen “on a case by-case basis under the direction of a healthcare provider,” Dr. Gaither emphasizes. It might be helpful to seek medical advice from both your obstetrician and rheumatologist to cover both maternal health and pregnancy outcomes.

It’s important to remember that discontinuing Enbrel due to pregnancy can cause worsening symptoms of the autoimmune or rheumatic disease it’s being taken to treat. If that is the case, pregnant women and their healthcare providers might consider restarting Enbrel. Sometimes, the benefits to the pregnant patient outweigh the potential risks to the fetus. Both maternal and fetal health matter.

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