Sodium oxybate Pregnancy and Breastfeeding Warnings

Sodium oxybate is also known as: Xyrem

Sodium oxybate Pregnancy Warnings

Sodium oxybate has been assigned to pregnancy category B by the FDA. Animal studies failed to reveal any evidence of teratogenicity. Although no controlled data in human pregnancy are available, literature reports of adverse fetal effects are lacking. Sodium oxybate should only be given during pregnancy when need has been clearly established.

Reproductive studies conducted in rabbits and rats at doses ranging from 1 to 3 times the maximum recommended human daily dose (on a mg/m2 basis) revealed no teratogenicity.

Sodium oxybate Breastfeeding Warnings

There are no data on the excretion of sodium oxybate into human milk. The manufacturer recommends that caution be used when administering sodium oxybate to nursing women.

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