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FDA Approves Bayer's Lampit For Treatment Of Chagas Disease In Children

Bayer said Friday that the United States Food and Drug Administration has approved Lampit or nifurtimox for use in pediatric patients --from birth to less than 18 years of age and weighing at least 2.5 kg-- for the treatment of Chagas disease caused by Trypanosoma cruzi.

Lampit is not approved in the U.S. for use in adults 18 years of age or older.

The company said that Lampit, an antiprotozoal medication will be available in a new, dividable tablet that can be split on the scored lines by hand.

According to prescribing instructions, the tablet is specially formulated to disperse in water, which can aid in the dosing and administration to pediatric patients who may have difficulty swallowing whole or half tablets.

Chagas disease is caused by the Trypanosoma cruzi parasite and is primarily transmitted to humans via the feces of infected triatomines, insects that are also known as "kissing bugs" where the disease is present.

Chagas disease can also be transmitted by infected organ transplantation, infected blood transfusion, during pregnancy or birth from an infected mother to her child, and less frequently through ingestion of contaminated food.

Although the disease can be curable when detected and treated soon after the infection, untreated individuals become carriers and move to the chronic phase of the disease. Approximately 30% of these people may experience life-threatening cardiovascular and gastrointestinal complications.

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