FDA

FDA warns of serious liver injury risk with Ocaliva in non-cirrhotic patients

December 13, 2024

FDA issued a warning about serious liver injury in patients without cirrhosis taking Ocaliva (obeticholic acid) for primary biliary cholangitis (PBC). This update follows a review of postmarket clinical trial data, which identified cases of severe liver injury, including instances leading to liver transplant. The risk of liver injury was notably higher in patients taking Ocaliva compared with those taking placebo. Despite previous restrictions on Ocaliva use in patients with advanced cirrhosis, some non-cirrhotic patients have also experienced severe liver damage.

Health care professionals should monitor liver tests frequently in patients being treated with Ocaliva to detect and address worsening liver function early. Based on the current data, it's not clear if this monitoring will be sufficient to address the risk of serious liver injury. Discontinue Ocaliva treatment with any evidence of liver disease progression or if efficacy is not established. Explain the signs and symptoms of worsening liver injury to patients receiving Ocaliva and direct them to seek medical attention immediately if they develop any such signs or symptoms.

Source:

FDA. (2024, December 12). Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis. https://www.fda.gov/drugs/drug-safety-and-availability/serious-liver-injury-being-observed-patients-without-cirrhosis-taking-ocaliva-obeticholic-acid-treat