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Sodium oxybate Pregnancy and Breastfeeding Warnings

Sodium oxybate is also known as: Xyrem

Medically reviewed on Apr 12, 2018

Sodium oxybate Pregnancy Warnings

Use is not recommended.

US FDA pregnancy category: C

Animal studies have shown no evidence of teratogenicity but embryolethality was reported. Data from a limited number of pregnant women exposed in the first trimester indicate a possible increased risk of spontaneous abortions. Limited data from pregnant patients during second and third trimesters indicate no malformative nor feto/neonatal toxicity of this drug.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Sodium oxybate Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Xyrem (sodium oxybate)." Orphan Medical, Minnetonka, MN.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Xyrem (sodium oxybate)." Orphan Medical, Minnetonka, MN.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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