Can you take Xyrem while pregnant?

Xyrem is not recommended during pregnancy because it readily crosses the placenta. Xyrem is a central nervous system (CNS) depressant that slows down brain activity, which may be detrimental to a developing baby. Xyrem should not be given to pregnant women unless the perceived benefits far outweigh the risks.

The effects of Xyrem have not been formally studied in labor or delivery and few pregnant women have received Xyrem (sodium oxybate). This means data on its effects during pregnancy are limited.

• In women given Xyrem during childbirth, newborns were very sleepy, causing a slight decrease in Apgar scores, although cardiovascular and respiratory measures were stable. The frequency of uterine contractions also fell 20 minutes after the injection.
• Research has shown that Xyrem quickly crosses from the mother’s bloodstream into the placenta, and can be detected in a newborn's bloodstream. The effects of this on an infant's subsequent growth, development, and maturation are unknown.
• A small number of pregnant women have been exposed to Xyrem during the first trimester. There appeared to be a possible increased risk in the number of spontaneous abortions. Babies of women exposed in the second or third trimester did not appear to suffer any birth defects or toxicity; however, very few women have been studied.

Although animal studies have not shown an increased risk of birth defects, there was an increased number of stillbirths and post-birth deaths in baby rats given sodium oxybate (Xyrem).

• Sodium oxybate given to pregnant rats during organogenesis did not appear to cause developmental toxicity or birth defects in baby rats. Organogenesis in humans occurs anywhere between the third to eighth week of gestation and is the stage during which three germ layers of the embryo form into the major organs of the body system.
• Sodium oxybate that was administered to rats throughout pregnancy and lactation resulted in an increased number of stillbirths, an increase in the number of deaths in the baby rats once born, and decreased growth rates in those baby rats that survived.

The FDA has not assigned a pregnancy category to Xyrem.

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