Sodium phenylbutyrate / taurursodiol Pregnancy and Breastfeeding Warnings

Brand names: Relyvrio

Medically reviewed by Drugs.com. Last updated on Dec 5, 2022.

Sodium phenylbutyrate / taurursodiol Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Oral administration of this combination drug in rats throughout pregnancy and lactation resulted in increased offspring mortality at all doses (0, 375, 750, or 1500 mg/kg/day) and pup deaths at the highest dose tested. 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.

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Sodium phenylbutyrate / taurursodiol Breastfeeding Warnings

Benefit should outweigh risk

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

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references

Further information

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