Animal studies have revealed evidence of embryofetal mortality and toxicity and skeletal malformations at oral doses causing maternal toxicity. In pregnant rats given 300 mg/kg/day orally (570 times the maximum recommended human dose [MRHD] based on AUC comparisons), maternal toxicity, embryofetal toxicity (increased embryofetal resorptions and/or deaths), and drug-related fetal skeletal malformations and variations suggesting delayed development (i.e., delayed ossification) were observed; no developmental toxicity was seen at 100 mg/kg/day (26 times the MRHD based on AUC comparisons). In pregnant rabbits given 150 mg/kg/day orally (155 times the MRHD based on AUC comparisons), maternal toxicity and excessive embryofetal mortality (due to postimplantation loss), but no drug-related malformations, were observed; no embryofetal mortality was seen at 50 mg/kg/day (16 times the MRHD based on AUC comparisons). With topical administration to pregnant rabbits, a decrease in fetal bodyweight was observed at 10% solution (36 times the MRHD based on AUC comparisons); no embryofetal toxicity was seen at 5% solution (26 times the MRHD based on AUC comparisons). 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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

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.

See references

Benefit should outweigh risk.

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

Comments:
-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 side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-This drug has not been studied during breastfeeding; since blood levels are very low after topical application to toenails, a measurable amount of drug entering the breast milk is unlikely.

See references