The U.S. FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the liver because it can cause serious harm. PBC is a rare, chronic disease affecting the ducts in the liver that carry bile, which helps with digestion. Some PBC patients with cirrhosis who took Ocaliva, especially those with evidence of advanced cirrhosis, developed liver failure, sometimes requiring liver transplant.

Based on the original clinical trials, FDA believes the benefits of Ocaliva outweigh the risks for PBC patients who do not have advanced cirrhosis. We will continue to monitor and evaluate the clinical benefit and adverse events of Ocaliva and will communicate any new information to the public if it becomes available.

We added a new Contraindication, FDA’s strongest warning, to the Ocaliva prescribing information and patient Medication Guide stating that Ocaliva should not be used in PBC patients with advanced cirrhosis. Advanced cirrhosis is defined as cirrhosis with current or prior evidence of liver decompensation (e.g., encephalopathy, coagulopathy) or portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia). We also revised the Boxed Warning, our most prominent warning, to include this information along with related warnings about this risk.