The FDA is warning physicians not to prescribe obeticholic acid (Ocaliva, Intercept) to patients with primary biliary cholangitis (PBC) who also have advanced cirrhosis.
The agency’s warning comes after regulators learned of at least 25 cases of liver failure in patients with PBC and advanced cirrhosis who took the drug. Some of those patients required liver transplantation, officials said. “After starting Ocaliva, the pace of the liver decompensation or failure reported suggested these adverse events, which resulted in liver transplant in a small number of cases, were related to the drug rather than progression of the underlying PBC,” the agency said in a drug safety communication. The cases were reported to the FDA Adverse Event Reporting System database from May 27, 2016, through Jan. 18, 2021.
According to the FDA, obeticholic acid, which was approved in 2016, can still be used safely in patients who have PBC but not advanced cirrhosis. In 2017, the agency warned physicians that some patients were receiving excessive dosages of the medication, leading to an increased risk for serious liver injury and death.
The agency has now added a section to the drug’s list of contraindications, indicating that it should not be used in patients with advanced cirrhosis, which the FDA defines as “cirrhosis with current or prior evidence of liver decompensation (e.g., encephalopathy, coagulopathy) or portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia).” The FDA also updated the drug’s boxed warning to include the new information.
The FDA urged clinicians to determine whether PBC patients have advanced cirrhosis before starting them on the medication and to conduct routine monitoring of their liver function for signs of liver-related adverse reactions and worsening cirrhosis.
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—GEN Staff