Corticosteroids

THE SAFETY OF SYSTEMIC CORTICOSTEROIDS 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:

The use of systemic corticosteroids during pregnancy has been associated with an increased risk of certain birth defects (cleft lip and cleft palate). Systemic corticosteroids should only be used if your doctor determines that the benefits of treatment justify the potential risks to your baby.

What are systemic corticosteroids?

Systemic corticosteroids are prescription medications that reduce inflammation in your body and lower the activity of your immune system. These medications are often prescribed if you have a disease where your immune system does not function properly, or if you have a condition caused by inflammation. Systemic means that these medications travel through your blood and affect your entire body. Systemic corticosteroids include those that are taken orally and those that are injected into either a vein or muscle, but NOT corticosteroids that are in the form of inhalers, eye drops, nasal sprays, or creams and lotions applied to the surface of your skin. Types of systemic corticosteroids that are available include: prednisone, prednisolone, cortisone, methylprednisolone, dexamethasone, and triamcinolone.

What are systemic corticosteroids used to treat?

Systemic corticosteroids are used to improve conditions that involve inflammation. They are also used to control the symptoms of many autoimmune diseases. An autoimmune disease is a condition where your body’s immune system attacks its own cells. Some examples of medical disorders that systemic corticosteroids are used to treat include: certain types of arthritis, some skin conditions (psoriasis or rashes), severe allergies or allergic reactions, some types of blood disorders, asthma, some digestive diseases, multiple sclerosis, and lupus. They can also be used to improve symptoms in people with leukemia or lymphomas. 

How do systemic corticosteroids work?

Systemic corticosteroids interfere with the activity of chemicals in the body that cause inflammation. They also lower the activity of immune cells in the body. Together, these actions help reduce inflammation and the immune system’s activity.

Systemic corticosteroids can cause numerous side effects if used for extended periods of time, including osteoporosis, heart problems, ulcers, menstrual irregularities, diabetes, cataracts, and electrolyte imbalances.    

If I am taking a systemic corticosteroid, can it harm my baby?

There is evidence that systemic corticosteroids can cause harm to your baby and increase the risk of certain types of birth defects. The FDA recommends that these medications should only be used if the benefits of treatment justify potential risks to the baby. Several studies have found that there may be an increased risk of cleft lip or cleft palate, which are birth defects involving the lip or mouth. Systemic corticosteroids may also cause the baby to be born with malfunctioning adrenal glands, which are organs that produce certain hormones in the body.

Evidence:

A recent review analyzed several different studies that tested whether systemic corticosteroids were associated with a higher risk of birth defects. This review found that expecting moms who take systemic corticosteroids during the first trimester of pregnancy may have a small increased risk of having a baby with cleft lip with or cleft palate. In several of the studies reviewed, the use of systemic corticosteroids was also associated with low birth weight and premature birth. However, after looking at available evidence, this review did not find that corticosteroids were associated with either premature birth or low birth weight. They found that premature birth was likely caused by the diseases that the moms had at the time of pregnancy and was not directly related to the use of systemic corticosteroids. They then concluded that low birth weight was likely associated with premature birth and not the systemic corticosteroids. This review also looked at the potential for systemic corticosteroids to cause gestational diabetes, but they did not have enough evidence to determine whether there was an association. Gestational diabetes causes high blood sugar in expecting moms and leads to health problems in babies. Although some studies reported a higher risk of gestational diabetes with the use of systemic corticosteroids, it is unknown if the mom’s medical conditions at the time of pregnancy could have been a factor.  

One of the studies that was analyzed by the review mentioned above looked at data from the National Birth Defect Prevention Study. When this study analyzed data from 1997 to 2002, they found that the use of systemic corticosteroids during pregnancy was associated with a higher risk of cleft lip and palate. However, when they used data from 2003 to 2009, they did not find this increased risk.

Another study looked at 51,973 expecting moms who were exposed to any corticosteroid during the first trimester of pregnancy. The study did not find an increased risk of cleft lip or palate with the use of systemic corticosteroids during pregnancy. A different review found that the use of systemic corticosteroids during pregnancy was associated with a higher risk of cleft palate and lip, but they found that the risk depended on the type of study analyzed.

Systemic corticosteroids can also cause babies to be born with adrenal glands that do not function properly. There was a report of this effect in a baby whose mom used a systemic corticosteroid during pregnancy. The baby was also born with electrolyte imbalances, high blood sugar, and low blood pressure after birth. In addition, there has been a higher rate of stillbirths (death of the baby in the womb) reported with the use of systemic corticosteroids during pregnancy. However, this may be linked to the conditions that the moms had during pregnancy, and not the systemic corticosteroids. Furthermore, there have been some reports of babies being born with an eye disorder (cataracts) to moms who used systemic corticosteroids during pregnancy.

Bottom line: Systemic corticosteroids should be avoided during pregnancy unless medically necessary. They have been shown to increase the risk of cleft lip and cleft palate. Studies have also reported higher rates of premature birth, low birth weight, and stillbirth in babies whose moms used a systemic corticosteroid during pregnancy. However, later reviews concluded that these associations were likely due to the diseases the moms had at the time of pregnancy, and not the systemic corticosteroids. In some cases, your doctor may decide that systemic corticosteroids are necessary for your treatment during pregnancy.

If I am taking a systemic corticosteroid and become pregnant, what should I do?

If you become pregnant while taking a systemic corticosteroid, you should contact your doctor immediately. Your doctor may decide to discontinue your medication until after the birth of your baby.

If I am taking a systemic corticosteroid, can I safely breastfeed my baby?

Systemic corticosteroids pass into breast milk and may cause harm to your baby. The FDA recommends that systemic corticosteroids should be used with caution in moms who are breastfeeding. For some systemic corticosteroids, such as dexamethasone, the FDA recommends that either nursing should be discontinued, or the drug should be discontinued prior to breastfeeding. If your doctor determines that a systemic corticosteroid is medically necessary, the lowest possible dose should be used to limit your baby’s exposure to the drug. High doses of these medications for long periods of time could potentially cause problems with your baby’s growth and development. They may also interfere with your baby’s ability to produce certain hormones. If higher doses are necessary, it is recommended to avoid breastfeeding for 4 hours after taking a systemic corticosteroid. Despite the potential risks of using systemic corticosteroids while nursing, the American Aca
demy of Pediatrics has categorized prednisone and prednisolone as usually compatible with breastfeeding. There is limited evidence on the safety of these medications in the breastfed baby. However, there have been no reports of health problems or harm to breastfed babies when systemic corticosteroids were used while nursing.

Bottom line: Systemic corticosteroids should be used with caution in nursing moms. It is possible that these medications could cause harm to breastfed babies, especially if the mom is taking a high dose. There is little evidence on the safety of these medications in the breastfed baby. At the current time, there have been no reports of harm or health problems in babies exposed to systemic corticosteroids through breast milk.

If I am taking a systemic corticosteroid, will it be more difficult to get pregnant?

Systemic corticosteroids can cause fertility problems in both men and women by interfering with the body’s natural balance of hormones. These medications also reduce sperm counts in men. If you are taking a systemic corticosteroid, you should contact your doctor before trying to become pregnant.

If I am taking a systemic corticosteroid, what should I know?

Systemic corticosteroids should be avoided during pregnancy unless medically necessary. They have been associated with an increased risk of cleft lip and cleft palate. There have also been some studies that reported higher rates of premature birth, low birth weight, and stillbirth when systemic corticosteroids were used during pregnancy, but these were likely attributed to conditions that the moms had while pregnant. In some cases, your doctor may determine that treatment with a systemic corticosteroid is necessary.

Systemic corticosteroids should be used cautiously in nursing moms. While there have been no reports of health problems in babies exposed to these medications from breast milk, systemic corticosteroids may cause problems with hormone production and growth 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 systemic corticosteroids during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert reports about autoimmune diseases here, asthma here, and psoriasis here.  Additional information can also be found in the links below. 

Resources for systemic corticosteroids during pregnancy and breastfeeding:

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

Cleveland Clinic: Corticosteroids.

Mayo Clinic: Corticosteroid (Oral Route, Parenteral Route).

Read the whole report
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.