THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:
Ammonia N 13 should only be given during pregnancy if clearly needed. The effects of ammonia N 13 on the developing baby are unknown, but this drug exposes your baby to radiation. Radiation increases the risk that your baby will develop childhood leukemia. It can also increase the risk of birth defects, miscarriage, restricted growth, or mental retardation.
What is ammonia N 13?
Ammonia N 13 is a type of radioactive drug that is used in imaging procedures to help diagnose certain medical conditions. Radioactive molecules, like ammonia N 13, travel to certain organs in your body, where they then emit radiation. The radiation is used to produce an image, which allows healthcare practitioners to determine if an organ is functioning properly. If ammonia N 13 is being used for an imaging procedure, your healthcare practitioner will inject it into one of your veins prior to the procedure. This drug is only given as an injection by a healthcare practitioner.
What is ammonia N 13 used for?
Ammonia N 13 is a radioactive drug that is injected prior to a positron emission tomography (PET) scan of the heart. The PET scan is used to evaluate the amount of blood flow through the heart in people who have coronary artery disease. Images of the heart can be taken at rest and while under stress. A PET scan with ammonia N 13 allows healthcare practitioners to view areas of your heart that may not be functioning properly and determine if certain procedures may help restore blood flow to your heart.
How does ammonia N 13 work?
Ammonia N 13 is called a radioactive tracer. The tracer enters your blood and travels to your heart muscle. Inside your heart, ammonia N 13 releases a small amount of radiation, which is used to produce images of your heart. Tissues in your heart that are damaged will absorb less ammonia N 13 than tissues that are functioning normally. These differences will show up as areas of differing brightness or color and help to identify damaged heart tissue.
If I am undergoing a procedure that requires the use of ammonia N 13, can it harm my baby?
The FDA warns that ammonia N 13 should only be given to expecting moms if clearly needed. It is unknown if ammonia N 13 can cause harm to your baby if used during pregnancy. There have been no studies looking at its effects on the developing baby. Your doctor will determine if a PET scan using ammonia N 13 is medically necessary, or if it can be delayed until after the birth of your baby. Ammonia N 13 is a radioactive drug, so it will expose you and your baby to radiation. Developing babies are more sensitive to the effects of radiation than adults because their organs are growing and developing. Your baby is most susceptible to the effects of radiation during the first trimester of pregnancy (2 to 8 weeks after conception). Radiation exposure during pregnancy has been shown to cause health problems in babies.
What are some of the harmful effects of radiation exposure during pregnancy?
PET scans using ammonia N 13 expose you to ionizing radiation because they emit particles, called gamma rays. Ionizing radiation can change your baby’s DNA (genetic material) and increase the risk of birth defects and cancer. The risk for noncancerous health problems in your baby depends on how much radiation you are exposed to during pregnancy. At doses of less than 0.05 Gy, exposure to ionizing radiation has not been associated with a higher risk of noncancerous health problems. Radiation doses of 0.05 Gy and higher can cause birth defects, growth restriction (babies born smaller than normal for their age), miscarriage, and mental retardation. On average, one PET scan exposes an adult to about 0.025 Gy of radiation.
According to the American Academy of Family Physicians, one diagnostic imaging procedure will not increase the risk of birth defects or miscarriage. However, according to the Society of Nuclear Medicine and Molecular Imaging (SNMM), the use of a hybrid PET/computed tomography (CT) scan to determine blood flow in the heart (a procedure that often uses ammonia N 13 as a radioactive tracer) is contraindicated during pregnancy, meaning that expecting moms should never undergo one of these procedures. This is because the risks of radiation to the baby are unknown. It is recommended for healthcare practitioners to use other diagnostic tests if necessary.
Although the risk of noncancerous health problems in your baby is dependent on the amount of radiation exposure, an increased risk of cancer is present regardless of radiation amount. Any amount of ionizing radiation during pregnancy increases the risk that your baby will develop childhood leukemia. This risk increases with higher amounts of radiation exposure.
Expecting moms who work with radioactive substances are also at risk for radiation exposure. Some experts recommend that expecting moms should not work with PET substances, such as ammonia N 13. The National Council on Radiation Protection (NCRP) recommends not to exceed a maximum of 0.5 mSV (or 0.0005 Gy) of radiation exposure per month for expecting moms who are exposed to radiation through their occupation.
Bottom line: Ammonia N 13 should only be given to expecting moms if there is a clear need. The drug exposes your baby to radiation and its effects on the unborn baby are unknown. Radiation exposure can increase the risk of birth defects, growth restriction, miscarriage, or mental retardation in your baby. It also increases the risk that your baby will develop childhood leukemia.
If I have recently received an injection of ammonia N 13 for a diagnostic imaging procedure and become pregnant, what should I do?
If you have recently undergone a procedure using ammonia N 13, such as a PET scan, and become pregnant, you should contact your doctor immediately. Your doctor can tell you how much radiation you were exposed to during the procedure and discuss the possible risks to your baby. If you are exposed to ionizing radiation early after conception (up to 2 weeks after the date of conception), there is a risk that the embryo will fail to implant, resulting in pregnancy loss.
If I have recently received an injection of ammonia N 13 for a diagnostic imaging procedure, can I safely breastfeed my baby?
The FDA recommends that breastfeeding moms should either avoid receiving ammonia N 13 or avoid breastfeeding 2 hours after the injection. During this 2-hour window, moms can use other sources of nutrition for their baby (such as infant formula or breast milk that was pumped prior to the ammonia N 13 injection). It is unknown whether ammonia N 13 passes into breast milk. However, ammonia N 13 could potentially expose your baby to harmful radiation. There have been no reports describing the effects of ammonia N 13 in breastfed babies. Additionally, moms who are breastfeeding should not work with radioactive substances used for PET scans, such as ammonia N 13.
Bottom line: Breastfeeding moms should either avoid receiving ammonia N 13 or discontinue breastfeeding for 2 hours after the ammonia N 13 injection. Moms can pump their milk prior to administration of ammonia N 13 and give their babies the pumped milk during the 2-hour period after the injection.
If I have recently received an injection of ammonia N 13 for a diagnostic imaging procedure, will it be more difficult to get pregnant?
Radiation can cause infertility in both men and women; however, the amount of radiation in a diagnostic imaging procedure is unlikely to affect fertility. The amount of radiation that you are exposed to will depend on the type and number of diagnostic procedures you receive. Ask your doctor to discuss the risks of radiation with you and to estimate your overall radiation exposure.
If I am taking ammonia N 13, what should I know?
Injections of ammonia N 13 should only be given to expecting moms if clearly needed. Ammonia N 13 is a radioactive substance and can expose your baby to radiat
ion. The effects of ammonia N 13 on your baby are unknown, but radiation increases the risk that your baby will develop childhood leukemia. Radiation can also increase the risk of birth defects, growth restriction, miscarriage, and mental retardation.
Breastfeeding moms should either avoid receiving ammonia N 13 or discontinue breastfeeding for 2 hours after the ammonia N 13 injection. It is unknown if ammonia N 13 passes into breast milk, but this medication could expose your baby to harmful radiation.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of ammonia N 13 during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert reports about heart and blood conditions here and about the individual medications used to treat heart and blood conditions here. Additional information can also be found in the resources below.
For more information about ammonia N 13 during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:
American Heart Association: Positron Emission Tomography (PET)
American Cancer Society: Understanding Radiation Risk from Imaging Tests
United States Department of Labor, Occupational Safety and Health Administration: Pregnant Workers
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.