Xywav Pregnancy Warnings
Animal studies have revealed evidence of decreased pup postnatal viability, weight gain, and increased stillbirths at 1000 mg/kg/day doses given throughout pregnancy and lactation. There are no controlled data in human pregnancy.
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.
The manufacturer makes no recommendation regarding use during pregnancy.
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.
See references
Xywav Breastfeeding Warnings
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
-This drug has been detected as gamma-hydroxybutyrate (GHB) in breastmilk after oral administration.
-The effects in the nursing infant and on milk production are unknown.
See references
