The FDA has approved the oral antibacterial rifamycin (Aemcolo) to treat adults with travelers' diarrhea, the agency announced on Nov. 16.
Compared to placebo, the drug significantly reduced symptoms in a randomized controlled trial of 264 adults with travelers' diarrhea in Guatemala and Mexico, according to the FDA. Safety of the drug, as taken orally for three to four days, was evaluated in two trials of 619 adults, and the most common side effects were headache and constipation, the FDA said.
The drug is indicated to treat cases of travelers' diarrhea caused by noninvasive strains of Escherichia coli that are not complicated by fever or blood in the stool. It is contraindicated in patients with a known hypersensitivity to the medication, its components, or any of the other antimicrobial agents in the rifamycin class, such as rifaximin, the agency noted.