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May 26, 2021FDA Restricts Use of Ocaliva in Some Patients
May 26, 2021 – The U.S. FDA has issued a safety communication regarding the use of Ocaliva® (obeticholic acid), manufactured by Intercept Pharmaceuticals, in certain patients who have primary biliary cholangitis (PBC). The agency has determined that there is a risk of serious liver injury in patients with PBC who take Ocaliva and have advanced cirrhosis (scarring of the liver).
PBC is a chronic autoimmune condition in which the immune system attacks, injures, and eventually destroys the bile ducts in the liver. This causes bile, a fluid secreted by the liver to aid digestion, to become trapped in the liver, leading to irreversible liver damage.
Over the last five years, the FDA has identified 25 cases of serious liver injury leading to liver decompensation (an acute deterioration in liver function) or liver failure associated with Ocaliva in patients diagnosed with PBC who had cirrhosis. In many cases, the patients had advanced cirrhosis before starting Ocaliva. The FDA has stated that the pace of the liver decompensation or failure suggested these adverse events were related to the medication and not progression of PBC.
Ocaliva’s prescribing information has been updated with a contraindication and black box warning that the drug should not be used in PBC patients who have advanced cirrhosis. Advanced cirrhosis is defined as current or prior evidence of liver decompensation or portal hypertension (raised pressure in the portal vein, which carries blood to the liver from other parts of the digestive system).
The FDA first approved Ocaliva in 2016 to treat patients diagnosed with PBC who have not responded well enough to treatment with ursodeoxycholic acid (UDCA). In clinical trials, Ocaliva improved liver test values for alkaline phosphatase (ALP) values, which may improve survival and symptoms for PBC patients. The FDA has determined that the benefits of Ocaliva continue to outweigh the risks for adults who have PBC without advanced cirrhosis and have had an inadequate response to or are unable to tolerate UDCA.