FDA Restricts Use of Ocaliva® in Some Primary Biliary Cholangitis (PBC) Patients
Obeticholic acid (Ocaliva®) is used to treat a rare, chronic liver disease known as primary biliary cholangitis (PCB). The FDA issued a Drug Safety Communication restricting the use of obeticholic acid (Ocaliva®) in patients having PBC who also have advanced cirrhosis of the liver. The FDA identified 25 PBC patients with cirrhosis who took obeticholic acid, especially those with evidence of advanced cirrhosis, who developed liver failure, sometimes requiring liver transplant. The FDA has added advanced cirrhosis as a contraindication in the prescribing information and updated the Boxed Warning. The FDA believes the benefits of obeticholic acid outweigh the risks for PBC patients who do not have advanced cirrhosis.
Recommendations for Patients
Talk to your health care professional about the new warnings.
Contact your provider immediately if you develop any of the following symptoms:
- Swollen belly
- Yellow eyes or skin
- Bloody or black stools
- Coughing up or vomiting blood
- Mental status changes
Contact your provider if these symptoms are severe or do not go away after a few days:
- Belly pain
- Nausea, vomiting, or diarrhea
- Loss of appetite or weight loss
- New or worsening tiredness
- Fever and chills
- Less frequent urination
Recommendations for Healthcare Professionals
- Determine and routinely monitor the patient for advanced cirrhosis (defined as cirrhosis with current or prior evidence of hepatic decompensation [e.g., encephalopathy, coagulopathy] or portal hypertension [e.g., ascites, gastroesophageal varices, persistent thrombocytopenia]) and clinically significant liver-related adverse reactions (acute-on-chronic liver disease with nausea, vomiting, diarrhea, jaundice, scleral icterus, and/or dark urine).
- Permanently discontinue obeticholic acid in patients with advanced cirrhosis or symptoms of clinically significant liver-related adverse reactions.
Report adverse events involving this or other medicines to the MedWatch program as recommended in the Indian Health Manual and include “IHS” in the reporter section (section G).
Instructions for reporting can be found online at the NPTC Pharmacovigilance website.
The complete Drug Safety Communication can be viewed on the FDA website .