The FDA is warning that Intercept Pharmaceutical’s liver disease drug, Ocaliva, is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death.
Despite the dosing and monitoring for patients recommended on the current drug label, patients are receiving excessive dosing, particularly a higher frequency of dosing. According to the FDA, nineteen patients taking Ocaliva have died; seven of these patients were taking the drug more frequently than is recommended.
The warning stems from a September 8 announcement from Intercept to healthcare providers stating that severe adverse events, including liver failure and death, can occur if physicians fail to follow the recommended dosing regimen for Ocaliva.
FDA is working with the New York-based drug manufacturer to address these safety concerns.
Read the FDA warning