Ammonul

THE SAFETY OF AMMONUL 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 MAY CAUSE HARM TO YOUR BABY:

Ammonul should only be used during pregnancy if medically necessary, as determined by your doctor. The data available on the use of Ammonul in pregnancy is limited. Two cases have reported the safe use of Ammonul during pregnancy.

What is Ammonul?

Ammonul is a life-saving medication that is given within a healthcare facility for people who have certain genetic deficiencies. It contains the active ingredients sodium phenylacetate and sodium benzoate. Ammonul is administered with an intravenous injection by a healthcare practitioner and is only available by prescription from your doctor.

What is Ammonul used to treat?

Ammonul is used to treat high levels of ammonia in the blood caused by a urea cycle disorder. A urea cycle disorder is a genetic disorder that causes a deficiency in urea, which is an enzyme (a type of protein) that removes ammonia from the blood. People with this disorder develop high ammonia levels that can eventually cause life-threatening encephalopathy (changes in brain function). Early symptoms of encephalopathy may include changes in personality or mood, impaired intellectual ability, extreme fatigue, loss of appetite, vomiting, and sleep disturbances. High ammonia levels and encephalopathy need to be treated immediately to prevent permanent brain damage and possible death.

How does Ammonul work?

The active ingredients contained in Ammonul (sodium phenylacetate and sodium benzoate) provide an alternative to urea to help remove ammonia from the body.

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

Ammonul should only be used during pregnancy if medically necessary, as determined by your doctor. No studies in animals or humans have looked at the safety of Ammonul in pregnancy. In many cases, treatment with Ammonul can treat a potentially life-threatening reaction or help control ammonia levels to prevent this type of reaction. Your doctor will determine if the benefits of treatment with this medication outweigh potential risks.

Pregnancy causes metabolic changes that can trigger life-threatening hyperammonemia (high ammonia levels in the blood) in expecting moms with urea cycle disorders. These can occur during pregnancy or up to 6 to 8 weeks after delivery. If you have a urea cycle disorder, your doctor will need to carefully plan a treatment strategy, which may include the use of Ammonul, to prevent hyperammonemia from occurring. In some cases, expecting moms may receive treatment for a urea cycle disorder if they are carrying a baby who has been determined to have a urea cycle disorder. Babies that have urea cycle disorders often experience severe hyperammonemia within the first few days after delivery, which can lead to brain damage or death. If they survive, many sustain brain injury with mental retardation. Some reports have shown that treating the pregnant mom with medications that help remove ammonia from the body can help prevent hyperammonemia in the newborn baby.

Evidence

A report describes a mom with a urea cycle disorder who was treated with sodium benzoate (one of the ingredients in Ammonul) daily and other medications used to treat urea cycle disorders. Proper treatment prevented high ammonia levels in the mom. She delivered a healthy baby without any complications.

Two reports described babies who were diagnosed with urea cycle disorders while their moms were pregnant. Both moms were treated with sodium benzoate intravenously. The sodium benzoate crossed the placenta in each case and treated both babies. Both babies were delivered safely and had no side effects from the sodium benzoate. The benzoate infusion was considered to be safe and effective at treating the 2 babies and removing extra ammonia from their bodies.

Two additional reports describe baby boys who were diagnosed with urea cycle disorders while their moms were pregnant. Their moms were treated with Ammonul shortly before birth. Immediately after delivery, the babies were also treated with Ammonul. The drug was present in the babies’ blood at birth. Both babies experienced a normal birth, had normal ammonia levels after birth, experienced no side effects from Ammonul, and did not experience any problems with brain function. At a few months of age, both boys underwent a liver transplant. Their development was normal at a few years of age.

Bottom line: Ammonul should only be used during pregnancy if medically necessary, as determined by your doctor. In some cases, Ammonul can be a life-saving treatment for the mom or baby. Your doctor will determine if the benefits of treatment outweigh potential risks. Case reports have demonstrated that Ammonul treatment during pregnancy was safe and may have protected the babies from potentially life-threatening encephalopathy at birth.

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

If you become pregnant and have recently received an infusion of Ammonul, you should contact your doctor immediately. Your doctor will consider the possible risks to your baby and determine if the medication is medically necessary.

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

Caution should be used if Ammonul is given to moms who are breastfeeding. It is unknown if the components of Ammonul pass into human breast milk. The effects of Ammonul on the breastfed baby have not been studied. Ammonul can be a life-saving medication, and, in some cases, your doctor may decide that the benefits of treatment outweigh the potential risks.

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

No studies have been conducted on the effects of Ammonul on fertility.

If I am taking Ammonul, what should I know?

Ammonul should only be used during pregnancy if medically necessary, as determined by your doctor. The data available on the use of Ammonul in pregnancy is limited. In some cases, your doctor may determine that the benefits of treatment with Ammonul outweigh the risks. If you or your baby have a urea cycle disorder, Ammonul may be a life-saving medication. Two case reports showed that the use of Ammonul during pregnancy was safe and may have protected the babies from potentially life-threatening encephalopathy.

Caution should be used if Ammonul is given to moms who are breastfeeding. It is unknown if Ammonul passes into breast milk, and its effects on the breastfed baby are unknown. Ammonul can be a life-saving medication for people with urea cycle disorders. Your doctor will determine if this medication is medically necessary.

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

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

You may find Pregistry's expert reports about a variety of conditions and the medications used to treat them here .   Additional information can also be found in the resources below. 

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

National Urea Cycle Disorders Foundation. What is a Urea Cycle Disorder?

Read the whole report
Last Updated: 18-06-2019
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.