Crisaborole topical Pregnancy Warnings
The manufacturer makes no recommendation regarding use during pregnancy.
AU TGA pregnancy category: B1
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 failed to reveal evidence of adverse embryofetal developmental effects when this drug was given orally at higher doses. Adverse effects to the fetus were present at oral doses that produced maternal toxicity (600 mg/kg/day) and included decreased fetal body weight, delayed ossification, stillbirths, and pup mortality. 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.
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Crisaborole topical Breastfeeding Warnings
The manufacturer makes no recommendation regarding use during lactation.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-This drug is absorbed systemically; however, lack of clinical data precludes a clear determination of the risk to a breastfed infant.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-Potential side effects in the breastfed child due to the drug or the mother's underlying condition should be considered.
-Patients who are nursing should not apply this product to the breast to avoid unintentional ingestion by the infant.
See references
