(HealthDay News) — Benznidazole has been approved by the US Food and Drug Administration to treat the tropical parasitic infection Chagas disease, in children aged 2 to 12.
In clinical testing, 55% to 60% of pediatric patients 6 to 12 years old treated with benznidazole had a negative antibody test for Chagas, the FDA said.
The most common side effects of the medication included stomach pain, rash, weight loss, headache, nausea, and vomiting. More serious risks could include serious skin reactions, nervous system effects, and bone marrow depression.
“The FDA is committed to making available safe and effective therapeutic options to treat tropical diseases,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.
The drug is manufactured by Chemo Research S.L., based in Spain.
US Food and Drug Administration. FDA approves first US treatment for Chagas disease [press release]. Published August 29, 2017. Accessed September 1, 2017.