Xifaxan Approved for Traveler's Diarrhea
The Food and Drug Administration (FDA) yesterday approved the marketing of rifaximin 200 mg oral tablets for the treatment of traveler's diarrhea caused by noninvasive strains of Escherichia coli.
Raleigh, North Carolina-based Salix Pharmaceuticals announced today that the antimicrobial product, which will be sold as Xifaxan, should be on the market in August.
The FDA-approved labeling (PDF) for rifaximin describes the product as a gastrointestinal-selective drug with minimal systemic absorption and notes that rifaximin cannot be used to treat systemic infections.
According to the labeling, rifaximin is indicated for use in patients 12 years or older. Patients whose diarrhea is complicated by fever or blood in the stool or caused by pathogens other than E. coli should not use the product.
Patients who have had an allergic reaction to rifaximin or any rifamycin antimicrobial drug must not use Xifaxan. The labeling warns that rifaximin use should be discontinued if diarrhea symptoms worsen or last for more than 24–48 hours. According to the labeling, health care providers who prescribe the product should be alert for symptoms of pseudomembranous colitis, a known complication of antimicrobial therapy.
Salix characterized rifaximin as well tolerated by patients during clinical trials of the product. In general, the frequency of adverse events among those who used the product was no greater than for patients who took a placebo, according to the product's labeling.