New Cases of Liver Transplants And Liver-Related Deaths Among Patients Who Did Not Have Cirrhosis
(Posted by Tom Lamb at Drug Injury Watch)
In a December 12, 2024, Drug Safety Communication the FDA said it had recently found cases of Ocaliva liver injury among patients who did not yet have cirrhosis, or scarring of the liver, including reports of liver transplants and liver-related deaths.
From that December 2024 FDA document, "Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis", we get this contextual information:
We previously identified that [primary biliary cholangitis (PBC)] patients with advanced cirrhosis were at risk of serious liver injury when taking Ocaliva and updated the prescribing information to restrict its use in these patients. FDA’s review of this required clinical trial found that some cases of liver injury in patients without cirrhosis resulted in liver transplant...
FDA restricted the use of Ocaliva in patients who have PBC with advanced cirrhosis of the liver in 2021 because it can cause serious harm in those patients, adding a new Contraindication to the Ocaliva prescribing information and patient Medication Guide. However, our recent review of case reports submitted to FDA* found that some patients with PBC and advanced cirrhosis were still taking the medicine despite these restrictions.
For additional background, we refer you to our previous Drug Injury Watch article about Ocaliva liver injury, "FDA Safety Evaluation Finds Ocaliva-related Liver Injury in Primary Biliary Cholangitis (PBC) Patients with Advanced Cirrhosis", written in May 2021.
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Returning to the December 2024 FDA Drug Safety Communication about Ocaliva liver injury, we get these details about the recently found cases:
FDA evaluated liver safety in the postmarket clinical trial in patients who were appropriate for Ocaliva treatment based on the approved indication in the prescribing information. Among these patients, the risk of both liver transplant and death were higher in patients receiving Ocaliva compared with those receiving placebo. Specifically, among patients for whom Ocaliva was indicated, which were those with a lower risk of progression to liver transplant or death, 7 of 81 who received Ocaliva needed a liver transplant compared to 1 of 68 patients who received placebo. An additional four patients receiving Ocaliva died, compared to one receiving placebo. Analyses evaluating the risk of liver transplant and death resulted in a hazard ratio of 4.77 (95% confidence interval: 1.03, 22.09) for patients without advanced cirrhosis and not contraindicated from receiving the drug. [Footnote omitted.]
As before, we will continue to monitor the drug regulatory realm for more developments on Ocaliva liver injury.
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