The FDA ( Food and Drug Administration ) has approved the use of Xifaxan for reduction in the risk of the recurrence of overt hepatic encephalopathy in patients with advanced liver disease. This is a new use for Xifaxan ( Rifaximin ), a drug that has been approved for the treatment of traveler’s diarrhea.

Hepatic 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 hepatic encephalopathy, and Xifaxan works by reducing these levels.

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

Xifaxan was not studied in patients with the most severe forms of liver disease. Since most patients were also taking Lactulose ( a synthetic sugar which helps prevent absorption of ammonia from the intestine ) during the trial, the efficacy of Xifaxan as a stand-alone treatment for hepatic encephalopathy could not be assessed.

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 ), nausea, gas, and headache.

Source: FDA, 2010

XagenaMedicine2010


Link: Xapedia - Medical Encyclopedia