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What is Chagas disease?
Chagas disease is an illness that can lead to serious heart and stomach problems, and even death.1 It affects as many as 8 million people in Mexico, Central America, and South America.2 In the United States, it is estimated that as many as 300,000 people are living with Chagas disease.2 If someone is infected, they may not feel any symptoms, which is why most people never realize they have Chagas disease.3
To learn more, please visit
Chagas Coalition Centers for Disease Control and Prevention
How is Chagas disease spread?
Most people get Chagas disease by contact with an infected triatomine bug, also known as a "kissing bug," "benchuca," "vinchuca," "chinche," or "barbeiro."4 The infected bugs pass parasites that cause Chagas disease through their poop after they bite.4 As people scratch the bite, a small amount of the bug's poop can get into the bloodstream.4 The disease can also be spread from mother to baby, by blood transfusion, or by receiving an organ transplant from an infected person.4 More rarely, it can be transmitted by eating contaminated food and accidental laboratory exposure.5
Chagas disease is not transmitted from person to person like a cold or through casual contact with an infected person or animals.4
How do you know if your child has Chagas disease?
A blood test is needed for you to know if your child has Chagas disease since the parasite can exist quietly in their body for decades before making them feel sick.4,6
Immediately after being infected (within a few weeks or months), your child may feel flu-like symptoms (fever, body aches) or experience swelling of the eyelid or at the bite mark.4
For most people, symptoms then go away and they don't ever get sick.4 But for some (fewer than half), there can be serious effects, such as sudden death fom an irregular heartbeat, a heart that doesn't pump blood very well because it's enlarged, trouble with digestion and bowel movements, and a higher risk of having a stroke.4
If you think your child has Chagas disease, be sure to talk to your child's doctor. Your child's doctor will examine your child and order a special blood test to see if your child is infected.4 It's also possible your child's doctor may send you to a specialist. Your child could be at risk for Chagas disease if they have lived in rural areas of Mexico, Central America, or South America; if they've seen the "kissing bug;" or if they've stayed in a house with walls that have cracks or crevices.4
Find out if your child should be tested for Chagas disease.
Learn more
How is Chagas disease treated?
It's important to remember that Chagas disease can be treated.7
The FDA has approved Benznidazole Tablets to treat Chagas disease in children 2 to 12 years of age.7 Benznidazole Tablets can be taken with or without food.7 Your child's dose will be decided by your doctor, according to your child's weight.7 For more information about Chagas disease, please ask your doctor.
What are the side effects with Benznidazole Tablets?
It is possible that your child will experience adverse reactions (side effects) if he or she takes Benznidazole Tablets. In clinical studies, the side effects that happened most often in children were stomach pain, rash, weight loss, headache, nausea, and joint pain.7 If these or any other side effects occur while your child is taking Benznidazole Tablets, call your doctor right away to find out what you should do.
IMPORTANT SAFETY AND PATIENT INFORMATION ABOUT BENZNIDAZOLE TABLETS
What are Benznidazole Tablets?
Benznidazole Tablets are a prescription medicine used to treat children 2 to 12 years of age with Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi.
This indication is approved under accelerated approval based on the number of treated patients who became Immunoglobulin G (IgG) antibody negative against the recombinant antigens of T cruzi. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Who should not take Benznidazole Tablets?
Do not take Benznidazole Tablets if you have a history of hypersensitivity reactions to benznidazole or other nitroimidazole derivatives or if you have taken disulfiram within the last two weeks. Do not consume alcoholic beverages or products containing propylene glycol for at least 3 days after therapy with Benznidazole Tablets. Do not take Benznidazole Tablets if you have Cockayne Syndrome.
Before you take Benznidazole Tablets, tell your healthcare professional about all of your medical conditions, including if you:
- May be pregnant or are planning to become pregnant. Benznidazole Tablets can cause harm to an unborn baby if given to a pregnant woman. Your doctor may perform a pregnancy test before starting treatment. Use effective contraception during treatment with Benznidazole Tablets and for 5 days after the final dose
- Are breastfeeding or plan to breastfeed. Due to the potential for serious adverse reactions and transmission of Chagas disease, breastfeeding is not recommended during treatment with Benznidazole Tablets
- Drink alcohol or consume products containing propylene glycol
Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I take Benznidazole Tablets?
- Read the Instructions for Use before taking Benznidazole Tablets and each time you get a refill
- Benznidazole Tablets should be taken exactly as your healthcare professional tells you to take it
- Benznidazole Tablets can be taken whole or broken at scored lines by mouth, with or without food
What should I avoid while taking Benznidazole Tablets?
- Do not drink alcohol or take disulfiram or products containing propylene glycol while taking Benznidazole Tablets
- Alcohol and products containing propylene glycol also should not be taken for at least 3 days after therapy with Benznidazole Tablets
What are the possible side effects of Benznidazole Tablets?
Benznidazole Tablets may cause:
- Abdominal pain
- Skin rash
- Decreased weight and/or decreased appetite
- Headache or dizziness
- Nausea and/or vomiting
- A change in white blood cell count (such as neutropenia or leukopenia)
- Hives and/or itching
The risk information provided here is not comprehensive. To learn more, talk about Benznidazole Tablets with your healthcare professional or pharmacist. Before taking Benznidazole Tablets, please read the full Prescribing Information here.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
References: 1. Protect your baby from Chagas disease. Centers for Disease Control and Prevention Website. https://www.cdc.gov/parasites/chagas/resources/poster_chagas_protect_your_baby.pdf. Accessed January 10, 2018. 2. Chagas disease in the Americas. Centers for Disease Control and Prevention website. https://www.cdc.gov/parasites/chagas/resources/chagasdiseaseintheamericas2015.pdf. Accessed December 15, 2017. 3. Detailed FAQs. Centers for Disease Control and Prevention website. https://www.cdc.gov/parasites/chagas/gen_info/detailed.html. Accessed December 15, 2017. 4. Chagas disease fact sheet. Centers for Disease Control and Prevention website. https://www.cdc.gov/parasites/chagas/resources/onepage.pdf. Accessed December 27, 2017. 5. Chagas disease provider fact sheet. Centers for Disease Control and Prevention website. https://www.cdc.gov/parasites/chagas/resources/factsheet.pdf. Accessed January 10, 2018. 6. Chatelain E. Chagas disease research and development: is there light at the end of the tunnel? Comp Struc Biotech J. 2017;15:98-103. 7. Benznidazole Tablets [package insert]. Florham Park, NJ: Exeltis USA; 2017.
Indications and Usage and Important Safety Information
INDICATIONS AND USAGE
Benznidazole Tablets, a nitroimidazole antimicrobial, is indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi.
This indication is approved under accelerated approval based on the number of treated patients who became Immunoglobulin G (IgG) antibody negative against the recombinant antigens of T cruzi. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.