Safety of a new chewable formulation of mebendazole for preventive chemotherapy interventions to treat young children in countries with moderate-to-high prevalence of soil transmitted helminth infections

The primary objective was to evaluate the safety and tolerability of the new chewable formulation of mebendazole to treat soil-transmitted helminth (sth) infections in children ≤10 years old with the goal of using this formulation in preventive chemotherapy programs and expand treatment to young children who are unable to swallow solid tablets. in this open-label,single-arm,phase 3 study conducted at pemba island,zanzibar,tanzania,children aged 2 to 10 years (median age: 4 years) were administered a single dose of the mebendazole 500 mg chewable tablet. safety was assessed 30 minutes after dose and 3 days later. of the 390 (98%) children who completed the study,195 (55%) had ≥1 sth infection and 157 (45%) had no infection at baseline. the most common sth infections were trichuris trichiura (51%),hookworm (16%),and ascaris lumbricoides (7%). treatment-emergent adverse events (teaes) were experienced by 11% of children. there was no difference in the percentage of children experiencing teaes between the age strata of 2-5 years and 6-10 years. diarrhea was reported only in children aged 2-5 years. no correlation was observed between the type or percentage of aes and presence or severity of infection. a single dose of mebendazole 500 mg chewable tablet was safe and well tolerated in children aged 2 to 10 years. © 2012 andrew j. friedman et al.