FDA approves Aemcolo to treat travellers diarrhea.-Cosmo Technologies

The FDA has 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 efficacy of Aemcolo was demonstrated in a randomized, placebo-controlled clinical trial in 264 adults with travelers� diarrhea in Guatemala and Mexico. It showed that Aemcolo significantly reduced symptoms of travelers� diarrhea compared to the placebo. The safety of Aemcolo, taken orally over three or four days, was evaluated in 619 adults with travelers� diarrhea in two controlled clinical trials. The most common adverse reactions with Aemcolo were headache and constipation. Aemcolo was not shown to be effective in patients with diarrhea complicated by fever and/or bloody stool or diarrhea due to pathogens other than noninvasive strains of E. coli and is not recommended for use in such patients. Aemcolo should not be used in patients with a known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents (e.g. rifaximin), or any of the components in Aemcolo.