Fosdenopterin Pregnancy and Breastfeeding Warnings

Brand names: Nulibry

Medically reviewed by Drugs.com. Last updated on Mar 6, 2024.

Fosdenopterin Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There are no data available to evaluate for a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes; animal studies have not been conducted.

Animal reproduction toxicology studies have not been conducted with this drug. 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.

See references

Fosdenopterin Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Unknown
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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