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Febuxostat Pregnancy and Breastfeeding Warnings

Febuxostat is also known as: Uloric

Medically reviewed on April 24, 2018

Febuxostat Pregnancy Warnings

Use is not recommended during pregnancy unless the benefit outweighs the risk to the fetus.
-Some experts recommend: Use should be avoided.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Animal models have revealed evidence of neonatal mortality and reductions in neonatal weight gain when rats were given oral doses up to 40 times the human plasma exposure (80 mg/day) during organogenesis through lactation. Limited human exposure data have not indicated adverse effects on the health of the fetus or newborn infant. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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

Febuxostat Breastfeeding Warnings

This drug is readily excreted in the breast milk of rats (milk:plasma ratio of 7.9 at 4 hours post-maternal dose). Reductions in offspring development and weaning index occurred when female rats were dosed at levels 25 times the maximum recommended human dose during lactation; maternal toxicity was observed.

Use is not recommended.
-Some experts recommend: Use with caution; benefit to mother should outweigh risk to the infant.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comment: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Uloric (febuxostat)." Takeda Pharmaceuticals America, Lincolnshire, IL.

References for breastfeeding information

  1. "Product Information. Uloric (febuxostat)." Takeda Pharmaceuticals America, Lincolnshire, IL.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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