Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication – Due to Risk of Serious Liver Injury, FDA Restricts Use of Ocaliva in Primary Biliary Cholangitis Patients with Advanced Cirrhosis

FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis with advanced cirrhosis of the liver because some patients with cirrhosis who took Ocaliva, especially those with evidence of advanced cirrhosis, developed liver failure