Lampit: genotox, carcinogenicity and repro: done or skipped?

“Based on the weight of evidence from these studies, nifurtimox is considered to be genotoxic and the product label for Lampit will include a Warning for genotoxicity.”

“Because the proposed treatment duration of nifurtimox is less than 6 months, a carcinogenicity assessment is not required.”

“In preliminary embryo-fetal studies in rats and mice and a comprehensive study in rabbits, nifurtimox produced dose-related maternal and/or fetal toxicity in all test species as well as a fetal malformation in rabbits.”

“Nifurtimox at high concentrations was shown to inhibit hERG channels with an estimated IC50 value of 98 mcM (28.2 mcg/ml). In a cardiovascular study in conscious telemetered dogs, QTc intervals were slightly increased at a nifurtimox dose of 80 mg/kg.”