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FDA Restricts Use of Ocaliva® in Some Primary Biliary Cholangitis (PBC) Patients

Obeticholic acid (Ocaliva®) is used to treat a rare, chronic liver disease known as primary biliary cholangitis (PCB). The FDA issued a Drug Safety Communication restricting the use of obeticholic acid (Ocaliva®) in patients having PBC who also have advanced cirrhosis of the liver. The FDA identified 25 PBC patients with cirrhosis who took obeticholic acid, especially those with evidence of advanced cirrhosis, who developed liver failure, sometimes requiring liver transplant. The FDA has added advanced cirrhosis as a contraindication in the prescribing information and updated the Boxed Warning. The FDA believes the benefits of obeticholic acid outweigh the risks for PBC patients who do not have advanced cirrhosis.

Report adverse events involving this or other medicines to the MedWatch program as recommended in the Indian Health Manual and include “IHS” in the reporter section (section G).

Instructions for reporting can be found online at the NPTC Pharmacovigilance website.

The complete Drug Safety Communication can be viewed on the FDA website Exit Disclaimer: You Are Leaving .