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Ocaliva safety update

On May 26, 2021, the U.S. Food and Drug Administration (FDA) released a drug safety alert restricting the use of Ocaliva® (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the liver because it can cause serious harm. Based on the original clinical trials, the FDA believes the benefits of Ocaliva outweigh the risks for PBC patients who do not have advanced cirrhosis.

The FDA will continue to update the public with any new information. Please consider this safety information when deciding whether to prescribe or continue obeticholic acid.

We will continue to provide safe prescribing updates. Thank you for your cooperation and for helping our members get and stay healthy.

Reference: FDA Drug Safety and Availability. FDA Drug Safety Communication: Ocaliva (obeticholic acid): Drug Safety Communication - Due to risk of serious liver injury, FDA restricts use of Ocaliva in primary biliary cholangitis (PBC) patients with advanced cirrhosis.

Published on: June 7, 2021, 15:49 p.m. ET
Last updated on: June 7, 2021, 15:51 p.m. ET