May 2021 FDA Drug Safety Communication: Ocaliva Label Change: Prescribing Information Will be Adding and Updating Warnings
Ocaliva (obeticholic acid) was listed on the "April - June 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)" report for "Liver disorder", and the status as of June 12, 2020, was "FDA is evaluating the need for regulatory action." Now we know more about the Ocaliva-related liver injury that the FDA was investigating and the Ocaliva label change which will be forthcoming.
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.
As background, in this October 10, 2020 post, "Potential Ocaliva - Liver Disorder Safety Signal Being Investigated by FDA as Side Effects Risk", we wrote about an Endpoints News article that revealed a previously little-known Ocaliva liver safety FDA evaluation. From our earlier article:
It was further reported in this October 2020 Endpoints News article that a spokesman for Intercept, the pharmaceutical company responsible for Ocaliva, said he anticipates the current Ocaliva liver safety FDA evaluation would take about 12 months.
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Returning to 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. The 25 cases include only those submitted to FDA* and those found in the medical literature,1 so there may be additional cases about which we are unaware (see Data Summary). 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.
*The cases were reported to the FDA Adverse Event Reporting System (FAERS) database from May 27, 2016, through January 18, 2021.
**We previously communicated about Ocaliva in September 2017 (risk of serious liver injury from overdosing) and February 2018 (new Boxed Warning to highlight correct dosing).
We will continue to monitor the medical literature as well as the drug regulatory realm for more developments pertaining to Ocaliva-related liver injury. Further, we will watch for the upcoming Ocaliva label change here in the US and perhaps elsewhere, such as Europe.
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