Xyrem

THE SAFETY OF XYREM 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:

Xyrem should not be taken during pregnancy unless the benefits of treatment outweigh the potential risks to the baby. There have been no human studies that have looked at the safety of Xyrem during pregnancy, but animal studies indicate that taking Xyrem during pregnancy may be harmful to the developing baby. Nursing infants exposed to this medication should be monitored for signs of sleepiness and confusion.

What is Xyrem?

Xyrem is a medication that is taken to treat extreme sleepiness throughout the day and temporary loss of muscle tone known as cataplexy. Xyrem is currently available as a brand name medication only. The active ingredient in Xyrem is sodium oxybate which is a central nervous system depressant. Xyrem is related to an illegal drug, gamma hydroxybutyrate (GHB). Xyrem is available as an oral solution and is taken once at bedtime and once 4 hours later. It is available only by prescription from your doctor. Due to the potential for abuse with Xyrem, the medication is classified as a controlled substance (C-III) and is only available by prescribers and in pharmacies certified to participate in the Xyrem Success Program

What is Xyrem used to treat?

Xyrem is used to treat symptoms associated with narcolepsy in children over 7 years old, adolescents, and adults. Narcolepsy is a neurological disorder that affects sleep and wakefulness. Day-to-day effects of this disorder may include excessive daytime sleepiness, episodes of falling asleep during daily activities, muscle weakness while awake (cataplexy), insomnia, vivid dreams or hallucinations, and sleep paralysis. Narcolepsy patients enter deep sleep (rapid eye movement, REM) more quickly than people without this disorder, resulting in symptoms of muscle weakness and vivid dreams. 

Pregnant women can experience narcolepsy as often as other people. You can read about narcolepsy and its impact on pregnancy here.

How does Xyrem work?

Xyrem is related to a neurotransmitter, gamma aminobutyric acid (GABA), and works by inhibiting some neurotransmitter (ex. norepinephrine, dopamine) activity in the brain.

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

There have been no human studies or case reports that have looked at the safety of this medication in pregnancy. Animal studies show that taking Xyrem during pregnancy has a low risk of causing harm to your baby. It is recommended that doctors only prescribe this medication during pregnancy after weighing the risks versus benefits.

Evidence from animal studies with Xyrem:

When Xyrem was given to rats and rabbits at doses equal to or up to three times the recommended human dose, no birth defects were observed in the offspring. Xyrem doses in rats that were equivalent to recommended human doses of the medication and given throughout pregnancy were associated with stillbirth and decreased weight gain in females and decreased growth in offspring. 

Evidence for the risks of Xyrem in human babies:

It is unknown if Xyrem crosses the human placenta to reach the developing baby. A case report of a woman who took GHB or ecstasy (a related drug) showed that she developed slow and shallow breathing during labor and delivery which was successfully treated with an oxygen face mask. The long-term effects of Xyrem on neonatal growth and development are unknown. Studies describing the use of injectable sodium oxybate for anesthesia in Cesarean section in the 1960’s reported successful delivery of the babies. However, maternal seizure, abnormal blood pressure in the arteries, and blood loss were reported in women during delivery. Some infants experienced sleepiness at birth.

Bottom line: Xyrem should not be taken during pregnancy unless the benefits of treatment outweigh the potential risks to the baby. There have been no human studies that have looked at the safety of Xyrem during pregnancy, but animal studies suggest this medication may be harmful to the developing baby.

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

If you are taking Xyrem and become pregnant, you should contact your doctor immediately. Your doctor will determine if your medication is medically necessary, or if it should be discontinued until after the birth of your baby.

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

Xyrem is expected to pass into breast milk. The effects of this medication on a nursing infant or maternal milk production are unknown, but there is potential that the infant may show signs of sleepiness and confusion. A case report of a nursing infant exposed to Xyrem over 6 months resulted in normal growth and development of the infant at 6 months follow-up. If continuing this medication while breastfeeding, it is advised to wait between bedtime doses and until more than 5 hours after the last bedtime dose, but before the next dose, to nurse an infant. One study recommended that women taking sodium oxybate discard their morning milk production to prevent side effects in their nursing babIes. The manufacturer of this medication recommends weighing the risks versus benefits before using it while breastfeeding. 

Bottom line: Xyrem passes into breast milk. Nursing infants exposed to this medication should be monitored for signs of sleepiness and confusion. It is recommended to wait until at least 5 hours after the second bedtime dose before breastfeeding.

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

Probably not. Rats who received oral doses of Xyrem similar to recommended human doses did not show impairment in fertility. 

If I am taking Xyrem, what should I know?

Xyrem should not be taken during pregnancy unless the benefits of treatment outweigh the potential risks to the baby. There have been no human studies that have looked at the safety of Xyrem during pregnancy, but animal studies suggest this medication may be harmful to the developing baby.

Nursing infants exposed to this medication should be monitored for signs of sleepiness and confusion. It is recommended to wait until at least 5 hours after the second bedtime dose before breastfeeding.

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

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

You may find Pregistry's expert report about narcolepsy here, and other sleep conditions here.   Additional information can also be found in the resources below. 

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

National Institute of Neurological Disorders and Stroke: Narcolepsy Fact Sheet

US Food and Drug Administration: Xyrem Prescribing Information

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.