Animal studies with oral dapsone have revealed evidence of embryolethality. Embryocidal effects were observed in rats and rabbits administered oral doses of 75 mg/kg/day and 150 mg/kg/day, respectively; these doses resulted in systemic exposures about 956 or 1407 times (rats) and 289 or 425 times (rabbits) the systemic exposure at the maximum recommended human dose of this topical drug (5% or 7.5% gel, respectively), based on AUC comparisons; effects were likely secondary to maternal toxicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

Use is not recommended.

AU TGA pregnancy category: B3
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

LactMed: Until more data available, an alternative topical agent may be preferred.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes (oral formulation)

Comments:
-This drug has not been studied during breastfeeding.
-The effects in the nursing infant are unknown.

Systemic absorption after topical application of this drug is minimal relative to oral dapsone administration. Systemic exposure from the topical gel 7.5% expected to be about 1% of the systemic exposure from a 100 mg oral dose.

Although it is unlikely the topical gel would affect breastfed infants, it should not be used during breastfeeding.

See references