Dermatologic/Anti-Infective (Topical—Pediculicide)
PREGNANCY RECOMMENDATION:No Human Data—Animal Data Suggest Low Risk
BREASTFEEDING RECOMMENDATION:Probably Compatible
No reports describing the use of abametapir in human pregnancy have been located. The drug will probably cross the placenta; however, based on the topical use of the drug and low plasma levels seen following systemic absorption, fetal exposure is probably negligible. Animal data did not show fetotoxic effects, even when administered orally. However, the absence of human pregnancy experience prevents a complete assessment of the embryofetal risk.
Abametapir probably enters breast milk. However, the total drug amount found in breast milk is likely to be negligible because the drug is for topical use, with low plasma levels found following systemic absorption. The topical lotion contains benzyl alcohol, which has been associated with serious and possibly fatal reactions in neonates, including “gasping syndrome” when consumed orally. Benzyl alcohol was found to be systemically absorbed following topical usage, but plasma levels were low (<4 mcg/mL). In addition, benzyl alcohol would be rapidly metabolized to benzoic acid in the maternal liver, and therefore, exposure to a breastfeeding newborn is not likely. Breastfeeding while using abametapir should be based on the mother’s clinical need for treatment.