First US Rx for Chagas Disease Approved

The US Food and Drug Administration (FDA) has approved the first United States treatment for Chagas disease.

The new medication is benznidazole. The FDA granted accelerated approval for it to be used in children with Chagas disease who are between the ages of 2 and 12.

Chagas disease is an infection that is caused by the parasite Trypanosoma cruzi. It can be spread in various ways, such as coming into contact with the feces of a certain insect, blood transfusions, or from a mother to her child during pregnancy.

Because Chagas disease is rare, the FDA granted benznidazole orphan product designation.

Although Chagas disease primarily affects those who live in rural parts of Latin America, an estimated 300,000 people across the United States may have Chagas disease.

After infection, there are two phases of Chagas disease: the acute phase and the chronic phase. Both phases can be symptom-free or life-threatening. Symptoms of Chagas disease can include fever, feeling tired, body aches, headache, rash, loss of appetite, diarrhea and vomiting — all symptoms that are not specific to Chagas disease.

The most recognized marker of acute Chagas disease is called Romaña's sign, which is swelling of the eyelids. The swelling is caused by the bug feces being accidentally rubbed into the eye or due to the bite wound being on the same side of the face as the swelling.

Benznidazole is available in tablet form and is taken two times a day for 60 days. Common side effects may include stomach pain, rash, weight loss, headache, and nausea and vomiting. This medication can lead to serious risks, such as serious skin reactions, bone marrow depression and nervous system effects.

Chemo Research, S. L., manufactures benznidazole.

Written By Anyssa Garza, PharmD, BCMAS