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Sodium oxybate Pregnancy and Breastfeeding Warnings

Sodium oxybate is also known as: Xyrem

Medically reviewed by Drugs.com. Last updated on Apr 12, 2018.

Sodium oxybate Pregnancy Warnings

Use is not recommended.

US FDA pregnancy category: Not assigned.

Risk Summary: Adequate data are not available on use of this drug in pregnant women to inform of a drug-related risk.

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 did not indicate malformative or feto-/neonatal toxicity of this drug.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Sodium oxybate Breastfeeding Warnings

Use is not recommended, and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-This drug has been detected as gamma-hydroxybutyrate (GHB) in breastmilk after oral administration.
-Sleep pattern changes in breastfed neonates have been observed.
-The effects on milk production are unknown.

See references

References for pregnancy information

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

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "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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