Two Drugs Approved for Irritable Bowel

Syndrome affects up to 15 percent of U.S. adults

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THURSDAY, May 28, 2015 (HealthDay News) -- Two new therapies to treat irritable bowel syndrome accompanied by diarrhea (IBS-D) in adults have been approved by the U.S. Food and Drug Administration.

IBS, characterized by loose stools and abdominal discomfort, affects 10 percent to 15 percent of U.S. adults, the FDA said in a news release.

The first drug, Viberzi, is taken twice daily with food. It stimulates nervous system receptors that can reduce bowel contractions. Common side effects include constipation, nausea and abdominal pain. The most serious adverse reaction is a type of muscular spasm that can lead to pancreatitis, the FDA said.

The second drug, Xifaxan, is taken orally three times daily for 14 days. And people with recurring symptoms can take a second 14-day dose if needed, the agency said. It was approved previously as an antibiotic to treat certain cases of "traveler's diarrhea." It's also been approved to treat overt hepatic encephalopathy, characterized by changes in brain function when the liver can't remove toxins from the blood.

The most serious side effect of Xifaxan is an increase in a liver enzyme found in the blood, or a severe type of infectious diarrhea called C. difficile. Nausea is a more common side effect.

Viberzi is produced by Cincinnati-based Patheon Pharmaceuticals and is distributed by Forest Laboratories, headquartered in the same city. Xifaxan is marketed by Salix Pharmaceuticals, based in Raleigh, N.C.

More information

Visit the FDA to learn more about these approvals.


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