FDA: Ocaliva still linked to ‘serious liver injury’ in PBC, even without cirrhosis
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The FDA has issued a safety alert warning that obeticholic acid carries an increased risk for “serious liver injury” among patients with primary biliary cholangitis, even those without advanced cirrhosis.
The FDA had previously identified that patients with PBC plus advanced cirrhosis exhibited higher risk for serious liver injury after receiving Ocaliva (obeticholic acid, Intercept Pharmaceuticals), and had restricted its use for this patient subset in May 2021.
However, in a recent FDA review of postmarketing data on obeticholic acid the agency received reports on 20 cases of liver injury among patients with noncirrhotic PBC, and “this risk was notably higher for patients taking Ocaliva compared with a placebo.”
In addition, despite obeticholic acid’s updated contraindication, the FDA “found that some patients with PBC and advanced cirrhosis were still taking the medicine despite these restrictions,” which has exacerbated poor liver-related outcomes associated with obeticholic acid.
In its postmarketing review, the FDA also reported that the risk for both liver transplant and death were higher among patients who received obeticholic acid vs. placebo: seven of 81 patients who received obeticholic acid needed a liver transplant vs. one of 68 patients who received placebo. In addition, the agency reported four patient deaths among those who received obeticholic acid compared with one patient death from the placebo group.
“Although we were not able to assess the appropriateness of Ocaliva use for most of these cases because of limited information, we identified three U.S. cases of liver-related events that occurred in patients for whom Ocaliva should have been discontinued based on progression of their liver disease as indicated in the 2021 safety labeling changes,” the agency stated in the alert. “This shows the importance of ongoing monitoring of liver tests and prompt action to withdraw Ocaliva if there is evidence of progression towards cirrhosis.”
Based on the available data, the FDA is advising health care providers to frequently monitor liver tests in patients receiving obeticholic acid to identify worsening liver function; however, the agency noted that it is currently uncertain if this measure would be adequate to curb the risk for serious liver injury. Providers are directed to discontinue obeticholic acid if they observe any signs of liver disease progression and should advise patients to contact them immediately if they experience telltale symptoms following treatment.
The FDA is encouraging health care providers and patients to report adverse events related to obeticholic acid use to the administration’s MedWatch Safety Information and Adverse Event Reporting Program, using the information in the “Contact FDA” box at the bottom of the page.
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