The Safety of Etanercept (Enbrel) during Pregnancy

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

This medication is considered to have a low risk when used during pregnancy

What is etanercept?

Etanercept is a prescription medication that stops chronic inflammation which causes autoimmune diseases. It is part of a class of drugs known as tumor necrosis factor inhibitors.

What is etanercept used to treat?

Etanercept is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, and plaque psoriasis.

How does etanercept work?

Etanercept is an antibody that blocks the production of certain inflammatory chemicals in the body that cause autoimmune disease.

If I am taking etanercept, can it harm my baby?

Etanercept does cross the human placenta to reach the developing baby. One small study found that maternal exposure to etanercept during conception or the first trimester, or by paternal exposure to the medication were not associated with an increased risk of birth defects. A  majority of available studies are case reports and some large registry studies; there is no consistent pattern of birth defects that can be directly connected to etanercept therapy during pregnancy. Some studies have suggested that etanercept is associated with an increased risk of prematurity and low birth weight, but no correlation has been proven. The effect of etanercept on long-term infant immune function is unknown; administration of live vaccines is typically delayed in infants exposed to in utero etanercept. Estimates of etanercept concentration in newborn infants exposed to the medication in the womb range from 3% to 32% of the maternal concentration. There is a study that collects data from pregnancies exposed to etanercept: OTIS Enbrel Pregnancy Registry.

If I am taking etanercept and become pregnant, what should I do?

Etanercept should only be used for treatment in pregnant women who need the medication and in whom the benefit will outweigh the risk to the developing baby. There is also some risk to the developing babies of women with untreated immune diseases such as rheumatoid arthritis.

If I am taking etanercept, can I safely breastfeed my baby?

Etanercept can be transferred through breast milk in small quantities. The manufacturer of etanercept recommends weighing the risks versus benefits to the infant and mother before using this medication while breastfeeding. It is important to talk to your doctor to decide if you should continue on etanercept during breastfeeding.

If I am taking etanercept, will it be more difficult to get pregnant?

The small amount of evidence available suggests that etanercept has no effect on male or female fertility.

If I am taking etanercept, what should I know?

Although etanercept may be associated with a small risk of side effects in the developing baby, serious birth defects are not increased with its use during pregnancy. It is always important to speak with your doctor before continuing this medication during conception or pregnancy.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of etanercept during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert reports about autoimmune diseases here,  reports about the individual medications used to treat immune disorders here, and a report about rheumatoid arthritis here. Additional information can also be found in the resources below. 

For more information about etanercept during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

Amgen: Enbrel Prescribing Information

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General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.