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# FDA Restricts Ocaliva Use in Some PBC Patients
- URL: https://www.fdaweb.com/fda-restricts-ocaliva-use-in-some-pbc-patients/
- Published: 2021-05-26T12:00:00.000Z
- Updated: 2026-09-14T17:00:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149406

FDA says it is restricting the use of Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the liver because it can cause serious harm. An agency [drug safety communication](https://www.fda.gov/drugs/drug-safety-and-availability/due-risk-serious-liver-injury-fda-restricts-use-ocaliva-primary-biliary-cholangitis-pbc-patients?ref=fdaweb.com) says some PBC patients who took Ocaliva, especially those with evidence of advanced cirrhosis, developed liver failure, sometimes requiring liver transplants.

The agency added a Contraindication to the drug labeling stating that it should not be used in PBC patients with advanced cirrhosis.

The notice says that in the years since Ocaliva’s 2016 accelerated approval, FDA has identified 25 cases of serious liver injury leading to liver decompensation or liver failure associated with Ocaliva in PBC patients with cirrhosis.