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Antibiotic Approved for Traveler's Diarrhea

FDA OKs New Type of Antibiotic to Prevent Montezuma's Revenge

WebMD Health News

May 26, 2004 -- The FDA has approved a new type of antibiotic that may not only prevent Montezuma's revenge from spoiling your vacation, but it may also help prevent the spread of antibiotic resistance.

Today the FDA approved Xifaxan, the first oral antibiotic for the treatment of traveler's diarrhea caused by infection with E. coli in people aged 12 and older.

The difference between Xifaxan and other oral antibiotics used to treat traveler's diarrhea is that it stays in the gut and is not absorbed into the blood stream.

Researchers say using a gut-selective antibiotic like Xifaxan to treat traveler's diarrhea rather than more powerful, antibiotics which get absorbed into the blood may help prevent the growth of bacteria that are resistant to antibiotics. This is an emerging problem that is making an increasing number of antibiotics ineffective against common bacterial infections.

Researchers say traveler's diarrhea, also known as Montezuma's revenge, affects up to 60% of international travelers and is particularly common among foreign visitors to Mexico, Latin America, Africa, and South Asia. The illness often causes short-term diarrhea and stomach pain but can also lead to long-lasting diarrhea or irritable bowel syndrome.

Xifaxan Shortens Duration of Traveler's Diarrhea

The FDA based its approval on the results of a clinical trial that showed that treatment of traveler's diarrhea with Xifaxan shortened the duration of diarrhea for the most common cause of the condition, E. coli. These bacteria are most often found in undercooked ground beef or contaminated food and water.

The drug's manufacturer, Salix Pharmaceuticals, says Xifaxan should be available in pharmacies in August but only by prescription.

Although the drug is generally well tolerated, studies show the most common side effects are flatulence, headache, abdominal pain, and spasm of the muscles surrounding the rectum.

The FDA cautions that Xifaxan should not be used in people with diarrhea complicated by fever or blood in the stool, or with diarrhea caused by infections other than E. coli.

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