FDA Sees New Ocaliva Liver Injuries

FDA says its review of postmarket clinical trial data identified cases of serious liver injury in patients being treated for primary biliary cholangitis (PBC) with Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) who did not have cirrhosis of the liver. A 12/12 agency drug safety communication says FDA previously identified the issue in PBC patients with advanced cirrhosis. As a result of that finding, the drug’s labeling was updated to restrict its use in those patients.

“FDA’s review of this required clinical trial found that some cases of liver injury in patients without cirrhosis resulted in liver transplant,” the notice says. “This risk was notably higher for patients taking Ocaliva compared with a placebo….”

The agency says frequent liver test monitoring is necessary to identify worsening liver function and ensure appropriate discontinuation of Ocaliva.