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New Approval for Treatment of Chagas Disease
FDA news release; 2017 Aug 29
The FDA has approved benznidazole for the treatment of Chagas disease. The drug is distributed by Chemo Research, with US offices in Florham Park, NJ.
Indications: Benznidazole tablets, a nitroimidazole antimicrobial, is indicated in pediatric patients aged 2 to 12 years for the treatment of Chagas disease caused by Trypanosoma cruzi.
Dosage/administration: In pediatric patients aged 2 to 12 years: total daily dose is 5 mg/kg to 8 mg/kg orally administered in 2 divided doses separated by approximately 12 hours for a duration of 60 days.
Safety/efficacy: The safety and efficacy of benznidazole were established in 2 placebo-controlled clinical trials in pediatric patients aged 6 to 12 years.
Adverse reactions: The most common adverse reactions observed were abdominal pain, rash, decreased weight, headache, nausea, vomiting, neutropenia, urticaria, pruritus, eosinophilia, and decreased appetite.
US Food and Drug Administration. FDA approved first U.S. treatment for Chagas disease. FDA Web site. August 29, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573942.htm. Accessed September 3, 2017.