FDA Warns of Serious Liver Injury Risk with Ocaliva (Obeticholic Acid) in Patients with Primary Biliary Cholangitis
FDA Warning:
The FDA has issued a warning about the risk of serious liver injury associated with Ocaliva (obeticholic acid), a medication used to treat primary biliary cholangitis (PBC), a rare chronic liver disease12.
Incorrect Dosing:
The FDA identified that some patients with moderate to severe decreases in liver function were receiving excessive dosing of Ocaliva, leading to an increased risk of serious liver injury and death12.
Liver Injury Cases:
The FDA reported 11 cases of serious liver injury with Ocaliva use, including 6 patients with moderate or severe liver impairment who were incorrectly dosed, resulting in 3 deaths12.
Monitoring and Dosing:
Healthcare professionals are advised to determine baseline liver function before starting Ocaliva and to follow the recommended dosing and monitoring guidelines to minimize the risk of liver injury13.
Boxed Warning:
Ocaliva has a boxed warning due to the risk of worsening liver function and liver failure, particularly in patients with liver cirrhosis, which can lead to the need for a liver transplant and can be fatal3.
Patient Education:
Patients should be educated on the symptoms of potential liver injury and should seek immediate medical attention if they experience any signs of worsening liver function3.
Sources:
1. https://www.modahealth.com/medical/drugwarnings/2017/ocalivadosing.shtml
2. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-about-serious-liver-injury-ocaliva-obeticholic-acid-rare