FDA Approves First US Treatment for Chagas Disease
The US Food and Drug Administration has approved benznidazole for the treatment of Chagas disease in children aged 2 to 12 years. This is the first treatment to receive approval in the United States for Chagas disease.
Approval was based on 2 placebo-controlled clinical trials that included pediatric patients aged 6 to 12 years. In both trials, more children who had received benznidazole experienced an antibody test change from positive to negative compared with children who had received a placebo.
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Additionally, the safety and appropriate dosing recommendations were determined in a study on the pharmacokinetics and safety of benznidazole that included pediatric patients aged 2 to 12 years.
Common adverse reactions to benznidazole included stomach pain, rash, decreased weight, headache, nausea, vomiting, abnormal white blood cell count, urticarial, pruritus, and decreased appetite. In addition, benznidazole was associated with an increased risk for serious skin reactions, nervous system effects, and bone marrow depression. Animals studies showed that benznidazole could cause fetal harm if administered to pregnant women.
FDA approves first U.S. treatment for Chagas disease [press release]. FDA. August 29, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573942.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed August 30, 2017.