Nineteen patients with primary biliary cholangitis (PBC) have died after taking obeticholic acid (Ocaliva, Intercept Pharmaceuticals), prompting the FDA to issue a warning about improper dosing of the medication, which the agency has identified as a likely cause in a majority of the deaths.
To lessen the risk, the agency is urging prescribers and other caregivers to conduct baseline liver function testing before starting patients on obeticholic acid. Such efforts can help determine the