Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.
On May 26, 2021, FDA announced restricting the use of Ocaliva (active ingredient obeticholic acid) in patients having primary biliary cholangitis or PBC with advanced cirrhosis of the liver because it can cause serious harm. PBC is a rare, chronic disease affecting the ducts in the liver that carry bile, which helps with digestion. Some PBC patients with cirrhosis who took Ocaliva, especially those with evidence of advanced cirrhosis, developed liver failure, sometimes requiring liver transplant.
Based on the original clinical trials, FDA believes the benefits of Ocaliva outweigh the risks for PBC patients who do not have advanced cirrhosis. We will continue to monitor and evaluate the clinical benefit and adverse events of Ocaliva and will communicate any new information to the public if it becomes available.
FDA added a new Contraindication to the Ocaliva prescribing information and patient Medication Guide stating that Ocaliva should not be used in PBC patients with advanced cirrhosis. . We also revised the Boxed Warning to include this information along with related warnings about this risk.
Ocaliva was approved in May 2016 and has been shown to improve the alkaline phosphatase liver test in patients who have not responded well enough to ursodeoxycholic acid.
Health care professionals should determine before starting Ocaliva whether a patient with PBC has advanced cirrhosis as it is contraindicated in these patients. Routinely monitor patients during Ocaliva treatment for progression of PBC with laboratory and clinical assessments. Permanently discontinue Ocaliva in patients with cirrhosis who progress to advanced cirrhosis.
Also monitor patients for clinically significant liver-related adverse reactions that may manifest as development of acute-on-chronic liver disease with nausea, vomiting, diarrhea, jaundice, scleral icterus, and/or dark urine. Permanently discontinue Ocaliva in patients developing these symptoms.
FDA identified 25 cases of serious liver injury leading to liver decompensation or liver failure associated with Ocaliva in PBC patients with cirrhosis. The 25 cases include only those submitted to FDA and those found in the medical literature,All of these patients were taking Ocaliva at recommended dosages.
Side effects involving Ocaliva should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.
A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at [email protected].
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- FDA Drug Safety Communication: Due to risk of serious liver injury, FDA restricts use of Ocaliva in primary biliary cholangitis (PBC) patients with advanced cirrhosis
- FDA Drug Safety Podcast: Due to risk of serious liver injury, FDA restricts use of Ocaliva in primary biliary cholangitis (PBC) patients with advanced cirrhosis