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FDA: Two Drugs Approved for Irritable Bowel Syndrome

U.S. Food and Drug Administration approves Viberzi (eluxadoline) and Xifaxan (rifaximin)

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

The first drug, Viberzi (eluxadoline), 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 spasm in the sphincter of Oddi that can lead to pancreatitis, the FDA said.

The second drug, Xifaxan (rifaximin), 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 to treat travelers’ diarrhea caused by E. coli and for reduction of the risk in adult patients of recurring overt hepatic encephalopathy. It’s also been approved to treat overt hepatic encephalopathy. The most serious side effect of Xifaxan is an increase in alanine aminotransferase. If diarrhea does not improve or worsens after treatment, the patient should be evaluated for C. difficile enterocolitis. Nausea is a more common side effect.

“For some people, IBS can be quite disabling, and no one medication works for all patients suffering from this gastrointestinal disorder,” Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in a statement. “The approval of two new therapies underscores the FDA’s commitment to providing additional treatment options for IBS patients and their doctors.”

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.

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