Inhaled Corticosteroids

THE SAFETY OF INHALED CORTICOSTEROIDS (ICSs) DURING PREGNANCY OR BREASTFEEDING

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 CAN CAUSE HARM TO YOUR BABY:
There is limited evidence available on the use of inhaled corticosteroids during pregnancy, but some studies have shown an increased risk of birth defects with these medications. Inhaled corticosteroids should be avoided during pregnancy unless the benefits of treatment outweigh the risks, as determined by your doctor. Your doctor may continue treatment with an inhaled corticosteroid during your pregnancy because treatment may be safer than having uncontrolled asthma.

What are inhaled corticosteroids? 

Inhaled corticosteroids (ICSs) are medications that are breathed into the lungs to help improve the symptoms of asthma and prevent asthma attacks. These medications are available as inhalers or nebulizer solutions. Types of ICSs that are available include: budesonide (Pulmicort), fluticasone propionate (Flovent), mometasone furoate (Asmanex), and beclomethasone dipropionate (Qvar). They are also available in combination products, such as budesonide/formoterol (Symbicort) and fluticasone/salmeterol (Advair). ICSs are only available by prescription from your doctor.

What are inhaled corticosteroids used to treat?

ICSs are used to control asthma symptoms and prevent asthma attacks. They are not used to treat attacks that have already started and are not effective for this purpose. Instead, ICSs are maintenance inhalers that, when used daily, will improve symptoms and lessen the number and severity of asthma attacks that you experience.

What is asthma?

Asthma is a chronic condition affecting the airways that carry air into and out of your lungs. Asthma leads to inflammation of the airways, making them sore and swollen. The airways become very sensitive and react to certain triggers in the environment. Once they react, they become narrower and reduce the amount of air that can reach your lungs, causing symptoms of shortness of breath, wheezing, coughing, and chest tightness. Asthma that is not well controlled can lead to potentially life-threatening attacks.

How do inhaled corticosteroids work?

ICSs interfere with the activity of cells that are involved with inflammation. This reduces swelling, inflammation, and mucus production in the airways of a person who has asthma. The airways also become less likely to react to asthma triggers, which stabilizes asthma and prevents attacks. It can take 1 to 3 weeks of regularly using ICSs to see an improvement in symptoms, with the maximum benefit seen after 3 months of use.

If I am taking an inhaled corticosteroid, can it harm my baby?

The FDA recommends that most ICSs should be avoided during pregnancy unless the benefits outweigh potential risks. Many studies and guidelines have concluded that treatment with asthma medications is safer than having asthma symptoms or asthma attacks during pregnancy.  Asthma attacks can be harmful to both the expecting mom and her developing baby. During an asthma attack, the expecting mom may have difficulty getting enough oxygen, which leads to the baby not getting enough oxygen.  Uncontrolled asthma can cause your baby to be born prematurely, at a low birth weight, or small for gestational age. In severe cases, it could result in death of the baby. Poorly controlled asthma can also lead to health problems in expecting moms, including preeclampsia or gestational diabetes. Of the available ICSs, budesonide is often preferred during pregnancy because it has the most safety data available. Your doctor will determine what type of asthma medication is safest and most beneficial for controlling your condition.

Evidence:

One study used the Swedish Medical Birth Register to look at 2014 babies who had a birth defect and whose mom had used inhaled budesonide (a type of ICS) during pregnancy.  No increased rates of birth defects were observed with the use of inhaled budesonide compared to rates in the general population. Another study used the Swedish Medical Birth Register to follow 2638 expecting moms who used inhaled budesonide during early pregnancy.  Babies born during the study were normal gestational age, birth weight, and length, and there was no increased rate of stillbirth (death of the baby in the womb).

A study looked at Canadian databases to review 4561 expecting moms with asthma (1821 of them used an ICS during the first trimester of pregnancy).  There was no increased risk of birth defects seen with the use of ICSs. Moderate doses of ICSs significantly decreased the rates of birth defects by 59% compared to those who did not use an ICS.

Another study found that the risk of birth defects was dependent on the dose of the ICS used. The study reviewed 4392 expecting moms who used an ICS daily at a dose of less than 1000 µg and 154 expecting moms who used an ICS at a dose of greater than 1000 µg per day. Expecting moms who used a low to moderate dose (less than 1000 µg daily) did not have an increased risk of birth defects compared to expecting moms with asthma who did not use an ICS. However, expecting moms who used higher doses of an ICS (greater than 1000 µg daily) were 63% more likely to have a baby with a birth defect than those taking low or moderate doses of an ICS.

One other study found that there was an increased risk of birth defects with the use of ICSs. The study looked at 6024 expecting moms who had used an ICS during pregnancy.  It was found that there was a significantly increased risk of anal atresia (a birth defect in the babys rectum).

Bottom line: ICSs should be avoided during pregnancy unless the benefits of treatment outweigh potential risks. There is limited data available for the use of these medications during pregnancy, and some studies have shown an increased risk of birth defects. Uncontrolled asthma also poses a serious risk to both you and your baby during pregnancy. Your doctor will determine if you should continue taking an ICS during your pregnancy.

If I am taking an inhaled corticosteroid and become pregnant, what should I do?

If you are taking an ICS and become pregnant, you should contact your doctor immediately. Your doctor will determine whether your medication should be continued, discontinued, or if a safer medication should be started instead.

If I am taking an inhaled corticosteroid, can I safely breastfeed my baby?

FDA drug labels for most ICSs recommend that these medications should be used in breastfeeding only when medically necessary and the benefits of treatment outweigh potential risks. There are no reports or studies that have looked at the effects of ICSs in the breastfed baby. One study analyzed the amount of inhaled budesonide that passed into breast milk.  It was determined that the medication passed into breast milk, but the amount that the baby would be exposed to was considered negligible. Despite the lack of information, your doctor may determine that ICSs are necessary for your asthma treatment while you are breastfeeding. The National Asthma Education and Prevention Program expert panel consider ICSs compatible with breastfeeding. 

Bottom line: ICSs should be used in breastfeeding only when the benefits of treatment outweigh potential risks. There is very little data about the safety of these medications in breastfeeding.

If I am taking an inhaled corticosteroid, will it be more difficult to get pregnant?

There are no studies that have looked at the effects of ICSs on fertility.

If I am taking an inhaled corticosteroid, what should I know?

ICSs should be avoided in pregnancy unless the benefits of treatment outweigh potential risks. There is limited evidence available on the safety of these medications during pregnancy, and some reviews have associated ICSs with an increased risk of birth defects. Additionally, higher doses of ICSs may increase the likelihood of birth defects. Asthma that is poorly controlled can also cause harm to your baby, including premature birth, low birth weight, small for gestational age at birth, or death. Your doctor will determine which treatment plan is best to control y
our asthma symptoms and provide the most benefit to both you and your baby.

ICSs should only be used in breastfeeding if they are medically necessary. There are no studies looking at the safety of ICSs in the breastfed baby.

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

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

You may find Pregistry’s expert report about asthma here or reports about the individual medications used to treat respiratory disorders here.  Additional information can also be found in the resources below. 

Resources for inhaled corticosteroids during pregnancy and breastfeeding:

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

 

Read the whole report
Last Updated: 31-01-2018
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.