Other safety alerts
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| The United States: FDA restricts use of Ocaliva in primary biliary cholangitis (PBC) patients with advanced cirrhosis due to risk of serious liver injury |
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The US Food and Drug Administration (FDA) announces that it is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (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. FDA 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, FDA’s strongest warning, to the Ocaliva prescribing information and patient medication guide stating that Ocaliva should not be used in PBC patients with advanced cirrhosis. Advanced cirrhosis is defined as cirrhosis with current or prior evidence of liver decompensation (e.g., encephalopathy, coagulopathy) or portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia). FDA also revised the Boxed Warning, its most prominent warning, to include this information along with related warnings about this risk.
In the five years since Ocaliva’s accelerated approval, FDA identified 25 cases of serious liver injury leading to liver decompensation or liver failure associated with Ocaliva in PBC patients with cirrhosis, both in those without clinical signs of cirrhosis (compensated) or in those with clinical signs of cirrhosis (decompensated). Many of these PBC patients had advanced cirrhosis before starting Ocaliva. The 25 cases include only those submitted to FDA and those found in the medical literature, so there may be additional cases about which FDA is unaware. All of these patients were taking Ocaliva at recommended dosages. After starting Ocaliva, the pace of the liver decompensation or failure reported suggested these adverse events, which resulted in liver transplant in a small number of cases, were related to the drug rather than progression of the underlying PBC.
Patients with PBC who have cirrhosis and are taking Ocaliva should talk to their health care professional about these new warnings. Contact their prescriber immediately if they develop any of the following symptoms, which may be signs of worsening liver injury or development of advanced cirrhosis:
- any of these specific symptoms: swollen belly; yellow eyes or skin; bloody or black stools; coughing up or vomiting blood; mental status changes such as confusion, slurred speech, mood swings, changes in personality, or increased sleepiness or difficulty waking up
- any of these general symptoms if they 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; weakness; fever and chills; lightheadedness; less frequent urination
Health care professionals should
- determine before starting Ocaliva whether a patient with PBC has advanced cirrhosis as the medicine is contraindicated in these patients.
- routinely monitor patients during Ocaliva treatment for progression of PBC with laboratory and clinical assessments to determine whether the medicine needs to be discontinued. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/due-risk-serious-liver-injury-fda-restricts-use-ocaliva-primary-biliary-cholangitis-pbc-patients
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, May 27, 2021
Issued at HKT 15:00
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