The FDA issued an Ocaliva FDA drug safety alert in December 2024 that may result in another Ocaliva label change. This alert was for cases of liver transplants and liver-related deaths among patients without pre-existing cirrhosis who used Ocaliva as a treatment for primary biliary cholangitis (PBC).
To provide context for this most recent Ocaliva FDA drug safety alert, we refer you to this article: “FDA Safety Evaluation Finds Ocaliva-related Liver Injury in Primary Biliary Cholangitis (PBC) Patients with Advanced Cirrhosis — May 2021 FDA Drug Safety Communication: Ocaliva Label Change: Prescribing Information Will be Adding and Updating Warnings”.
The current version of the Prescribing Information document for Ocaliva (Revised: 5/2022) has a so-called Black Box Warning for cases of serious liver injury involving patients with diagnosed cirrhosis who used Ocaliva. Specifically, this Black Box Warning text was added to the Ocaliva drug label in May 2021:
WARNING: HEPATIC DECOMPENSATION AND FAILURE IN PRIMARY BILIARY CHOLANGITIS PATIENTS WITH CIRRHOSIS
- Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with OCALIVA treatment in primary biliary cholangitis (PBC) patients with either compensated or decompensated cirrhosis [see Warnings and Precautions (5.1)].
- OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal hypertension [see Contraindications (4)].
- Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation; have compensated cirrhosis and develop evidence of portal hypertension; or experience clinically significant hepatic adverse reactions while on treatment [see Dosage and Administration (2.3), Warnings and Precautions (5.1)].
We will watch to see whether this December 2024 Ocaliva FDA drug safety alert about cases of serious liver injury among patients without pre-existing cirrhosis results in another Ocaliva label change involving the Black Box Warning or other parts of the Prescribing Information document during the first part of 2025.
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