The U.S. Food and Drug Administration (FDA) has placed restrictions on the use of obeticholic acid (Ocaliva of Intercept Pharmaceuticals) in patients with primary biliary cholangitis (PBC) and advanced cirrhosis due to risk for serious liver injury. The restriction has caused Intercept Pharmaceuticals to place an additional warning on the label. Based on clinical trial data, for patients that do not have advanced cirrhosis or PBC, the FDA still recommends Ocaliva as its benefits are believed to outweigh the risks. Since the initial accelerated approval of Ocaliva in combination with ursodeoxycholic (UDCA), the FDA has identified 25 serious liver injury cases that led to either liver failure or decompensation in patients taking the recommended doses.
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