FDA approves new treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli - Drug Information Update

The U.S. Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. The most common adverse reactions with Aemcolo were headache and constipation. Travelers’ diarrhea is the most common travel-related illness, affecting an estimated 10–40 percent of travelers worldwide each year. Travelers' diarrhea is defined by having three or more unformed stools in 24 hours, in a person who is traveling. It is caused by a variety of pathogens, but most commonly bacteria found in food and water. The highest-risk destinations are in most of Asia as well as the Middle East, Africa, Mexico, and Central and South America. The FDA granted Aemcolo a Qualified Infectious Disease Product (QIDP) designation. QIDP designation is given to antibacterial products that treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. As part of QIDP designation, the Aemcolo marketing application was granted Priority Review under which the FDA’s goal is to take action on an application within an expedited time frame. For more information, please visit: Aemcolo