Humalog

THE SAFETY OF AFREZZA 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:
Afrezza should not be taken during pregnancy unless the benefits of treatment outweigh the potential risks, as determined by your doctor. Afrezza is a novel form of insulin delivery and is the only inhaled insulin formulation on the market. There is very little data on the use of Afrezza in pregnancy. Therefore, many experts do not recommend its use in expecting moms with diabetes.

What is Afrezza?

Afrezza contains rapid-acting human insulin. It is a novel form of insulin therapy that is available as an inhaled medication that you breathe into the lungs. This medication is only available by prescription from your doctor.

What is Afrezza used to treat?

Afrezza is used to treat Type 1 and 2 diabetes in people who need insulin to manage their blood sugar. Diabetes is a disease in which blood sugar levels are consistently elevated. When you eat foods with carbohydrates, these carbohydrates get converted to glucose, or sugar, causing your blood sugar to rise. Increased blood sugar causes your pancreas to release a hormone called insulin. Insulin helps your body get the energy it needs by telling your cells to absorb glucose. This, in turn, lowers your blood sugar levels. People with diabetes either don't make enough insulin or have insulin but it no longer functions properly within the body. In Type 1 diabetes, your body does not make any insulin, while in Type 2 diabetes, your body either does not make enough insulin or the insulin that you have is not working effectively. Without insulin, glucose remains in your blood, leading to continuously elevated blood sugar levels.

How does Afrezza work?

Afrezza provides human insulin for people with diabetes to help control blood sugar levels. It is a rapid-acting insulin taken at the start of meals. Diabetics often need both a short and a long-acting insulin to manage their blood sugar. Afrezza will start working 12 to 15 minutes after you take it, but after about 3 hours, the medication will have already been eliminated from your body. Therefore, if your doctor has determined that you need a long-acting insulin, you will need to use a long-acting injectable insulin in addition to Afrezza.

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

Afrezza should not be used during pregnancy unless the benefits of treatment outweigh the potential risks to the baby, as determined by your doctor. Your doctor will determine if your medication is medically necessary, or if an alternative therapy can be prescribed. Afrezza is the only type of inhaled insulin on the market. There is very limited data on the use of this form of insulin in expecting moms. Afrezza contains particles that are used to transport the insulin to your lungs. The effects of these transport particles are unknown. Due to the lack of data available, many experts do not recommend the use of Afrezza during pregnancy. For expecting moms who require insulin treatment during pregnancy, experts recommend using traditional injectable insulin formulations.

Expecting moms with uncontrolled diabetes have about a 3 to 5 times higher risk of having a baby with a birth defect. Serious life-threatening birth defects have been reported in babies born to moms with diabetes, including birth defects in the heart, digestive system, kidneys, bones, brain, spine, and spinal cord. Birth defects are the highest cause of death in babies whose moms have diabetes. The risk of having a baby with birth defects is strongly related to high blood sugar levels. The risk of birth defects appears to be highest when blood sugar levels are uncontrolled during the first trimester of pregnancy.

In addition to the risk of birth defects, expecting moms with diabetes have a higher risk of miscarriage, premature delivery, or having a baby who is large for gestational age at birth. These moms also have a higher risk of having a baby with other health problems. One study looked at 260 expecting moms with diabetes. Two-thirds of these expecting moms had a baby with a health problem at birth, including low blood sugar levels, low calcium levels, high bilirubin (which could lead to seizures and brain damage), and a type of blood disorder characterized by thicker than normal blood. There was also a higher rate of infant death compared to expecting moms without diabetes.

Adequately controlled blood sugar levels can help improve outcomes for expecting moms with diabetes. Some experts consider insulin to be the drug of choice for diabetes during pregnancy. Additionally, many experts believe that insulin is the only treatment that can maintain well-controlled blood sugar levels during pregnancy. Studies have not reported an association between human insulin use and birth defects. Insulin is a naturally occurring hormone and is considered compatible with pregnancy by some experts. However, animal insulin formulations (bovine or porcine from cows or pigs) are not recommended during pregnancy.

Bottom line: Afrezza (inhaled human insulin) should not be used during pregnancy unless the benefits of treatment outweigh the potential risks to the baby, as determined by your doctor. Expecting moms with uncontrolled diabetes have a higher risk of miscarriage or having a baby with birth defects or other health problems. There is very little data on the use of Afrezza in expecting moms, and some experts recommend traditional injectable insulin instead of this type of inhaled insulin therapy for the treatment of diabetes in expecting moms.

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

If you are taking Afrezza and become pregnant, you should contact your doctor immediately. Your doctor may decide to discontinue Afrezza until after the birth of your baby or prescribe an alternative therapy.

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

For breastfeeding moms who are taking Afrezza, the FDA recommends that either the medication or breastfeeding should be discontinued. Your doctor will determine if your medication is medically necessary, or if an alternative therapy can be prescribed. There are no studies or case reports that have looked at the use of Afrezza while breastfeeding. Insulin and the transport particles in Afrezza have been found to pass into breast milk in animal studies. Therefore, it is possible that these substances will pass into human breast milk. The effects of these substances on the breastfed baby are unknown. Many experts recommend avoiding Afrezza while breastfeeding.

Bottom line: For breastfeeding moms who are taking Afrezza, it is recommended to either discontinue the medication or breastfeeding. Afrezza contains insulin and transport particles that likely pass into breast milk. The effects of these substances on the breastfed baby are unknown.

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

Treating uncontrolled diabetes can help improve fertility in women. If your doctor determines that Afrezza is necessary for your treatment, this medication could help improve fertility. Women with diabetes often experience menstrual irregularities, including infrequent or absent menstrual bleeding. Controlling blood sugar levels can help improve these irregularities and increase fertility.

If I am taking Afrezza, what should I know?

Afrezza should not be used during pregnancy unless the benefits of treatment outweigh the potential risks, as determined by your doctor. There is very limited data on the use of Afrezza during pregnancy. Afrezza is a novel form of insulin therapy and is the only inhaled insulin formulation available. For these reasons, many experts recommend traditional injectable insulin instead of Afrezza in expecting moms with diabetes.

For breastfeeding moms who are taking Afrezza, it is recommended to either discontinue the medication or breastfeeding. Afrezza contains human insulin and transport particles, which likely pass into breast milk. The effects of these substances on the breastfed baby are unknown.

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

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

You may find Pregistry's expert report about diabetes here, and reports about the individual medications used to treat diabetes here.   Additional information can also be found in the resources below. 

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

American Diabetes Association: Insulin Basics

National Institute of Diabetes and Digestive and Kidney Diseases: What is Diabetes?

Centers for Disease Control and Prevention: About Diabetes.

National Institute of Diabetes and Digestive and Kidney Diseases: Insulin, Medicines, & Other Diabetes Treatments.

Read the whole report
Last Updated: 24-03-2019
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.