Patients on nifurtimox for Chagas disease frequently report adverse events, mostly mild
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Most patients who received nifurtimox for the treatment of Chagas disease during a 20-year CDC-sponsored program reported adverse events, according to a study published Thursday in MMWR.
Although most of the reported adverse events were mild in nature, the authors of the new report said health care providers “should be aware of the frequency and profile of adverse events when counseling patients and prescribing nifurtimox” as it becomes more widely available under a recent FDA approval.
Andrew Abbott, MD, an Epidemic Intelligence Service officer in the CDC’s Division of Parasitic Diseases and Malaria, and colleagues noted that the CDC “was the sole provider of nifurtimox in the United States for the 20 years before the drug became commercially available” in October 2020.
“This report represents the most complete description of the patients treated and adverse events reported during that time,” they wrote.
According to the CDC, Chagas disease is primarily transmitted by triatomine bugs — known as “kissing bugs” because they frequently bite people on the face — carrying the parasite Trypanosoma cruzi, but also from mother to unborn child. It is endemic in rural areas of Latin America but also occurs in the United States, where around 300,000 people are estimated to be living with the infection.
The FDA approved nifurtimox on Aug. 7, 2020, for the treatment of Chagas disease in patients aged younger than 18 years and weighing less than or equal to 5.5 lbs. Before that, it was only available through the CDC under an institutional review board-approved Investigational New Drug treatment protocol.
Between Jan. 1, 2001, and Jan. 25, 2021, the CDC released nifurtimox for 336 patients, 22 of whom did not start treatment. Patients were most frequently from California (n = 115) and had an average age of 37 years, with 27 patients being younger than 18 years, 246 being between 18 and 50 years, and 59 being older than 50 years. Additionally, nearly 60% of patients were female (58.9%; n = 196).
Of the 314 patients who started treatment, data on adverse events were available for 243. Among those, 222 reported at least one adverse event, with a total of 1,155 being reported. According to the report, most adverse events were gastrointestinal (68.7%), neurologic (60.5%) and constitutional (46.5%). The most common were nausea (50.6%), anorexia (46.1%), weight loss (35%), headache (33.3%) and abdominal pain (23.1%).
Among the adverse events, 680 (65.3%) were described as mild, 254 (24.4%) as moderate and 108 (10.4%) as severe. The most frequently reported severe events were depression (22.6%), peripheral neuropathy (18.5%), paresthesia (17.9%) and dizziness/vertigo (17.2%).
Abbott and colleagues said providers and health departments with questions about Chagas disease can contact the CDC’s Parasitic Diseases Branch by phone at 404-718-4745 or email at parasites@cdc.gov, or review the CDC’s website: https://www.cdc.gov/parasites/chagas.
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