Fecal microbiota spores, live Pregnancy and Breastfeeding Warnings

Brand names: Vowst

Medically reviewed by Drugs.com. Last updated on Dec 6, 2023.

Fecal microbiota spores, live Pregnancy Warnings

Safety has not been established 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.

Animal studies have not been reported. 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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Fecal microbiota spores, live Breastfeeding Warnings

Safety has not been established.

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

Comments:
-There is no information on the presence of this drug in human milk or the effects on milk production.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

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Further information

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