U.S. FDA approves new use of Xifaxan for patients with liver disease

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U.S. FDA approves new use of Xifaxan for patients with liver diseaseU.S. FDA approves new use of Xifaxan for patients with liver diseaseThe U.S. Food and Drug Administration on Thursday approved the use of Xifaxan for reduction in the risk of the recurrence of overt hepatic encephalopathy (HE) in patients with advanced liver disease.#x This is a new use for Xifaxan (rifaximin), a drug that has been approved for the treatment of traveler's diarrhea.

State FlagsHepatic encephalopathy is a worsening of brain function that can occur in patients whose liver can no longer remove toxins from the blood. Increased levels of ammonia in the blood are thought to play a role in the development of HE,State Flagsand Xifaxan works by reducing these levels.

"The approval of Xifaxan for this new indication provides an additional treatment option for patients with liver disease," said Joyce Korvick, deputy director for safety of FDA's Division of Gastroenterology Products. "Hepatic encephalopathy occurs commonly in patients with liver disease, and there are few effective treatments for this serious condition."

#x The efficacy of Xifaxan was established in a randomized placebo- controlled clinical trial of adult patients from the United States,Thermal Plate, Canada, and Russia. Patients with liver disease who entered the trial had no or mild symptoms of HE. Patients treated with Xifaxan were less likely to develop HE during the trial, compared to placebo-treated patients.

The most common adverse reactions reported with the use of Xifaxan in patients with liver disease include swelling of the arms and legs (peripheral edema),#x nausea, gas, and headache.State Flags
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