Benznidazole has been approved by the U.S. Food and Drug Administration to treat the tropical parasitic infection Chagas, or “kissing bug” disease, in children aged 2 to 12.
“”The FDA is committed to making available safe and effective therapeutic options to treat tropical diseases,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Chagas, also called American trypanosomiasis, may be spread through contact with insect feces, during blood transfusion or from a mother to child during pregnancy, the FDA said in a news release Tuesday. Left untreated, it can lead to serious heart problems, and affect swallowing and digestion.
An estimated 300,000 people in the United States are believed to be infected with Chagas, the FDA said.
In clinical testing, 55 percent to 60 percent of people 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 skin reactions, nervous system problems and bone marrow issues.
The drug is manufactured by Chemo Research S.L., based in Spain.
The FDA has more on Chagas disease.