We now know more about the Ocaliva-related liver injury “safety signal” that the FDA has been investigating over the past year, and as a result of that Ocaliva FDA safety evaluation there will be an Ocaliva label change with new warnings.
On May 26, 2021, this FDA Drug Safety Communication about Ocaliva, “Due to risk of serious liver injury, FDA restricts use of Ocaliva in primary biliary cholangitis (PBC) patients with advanced cirrhosis”, was issued. This document announced the FDA’s findings of Ocaliva-related liver injury and informed that Intercept Pharmaceuticals Inc. would be adding and updating the Ocaliva Prescribing Information, or drug label.
From the May 2021 Ocaliva FDA Drug Safety Communication we get this statement about what the FDA is doing:
We 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). We also revised the Boxed Warning, our most prominent warning, to include this information along with related warnings about this risk.
And later in the May 2021 Ocaliva FDA Drug Safety Communication about a “new” Ocaliva-related liver injury and the Ocaliva label change, here is what the FDA found during its Ocaliva liver safety evaluation:
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…. 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.
We are investigating possible Ocaliva drug injury lawsuits that would be filed against Intercept Pharmaceuticals, the responsible drug company, for patients who have been diagnosed with these serious possible Ocaliva side effects.[Read article in full at original source]