Following a review of postmarket clinical trial data, the FDA identified several cases of serious liver injury among patients using Ocaliva, with some requiring liver transplants, according to a Dec. 12 news release from the agency. The risk of liver injury was found to be higher for patients taking Ocaliva compared to a placebo.
In 2021, the FDA restricted the use of Ocaliva in PBC patients with advanced cirrhosis due to the risk of serious harm, adding a contraindication to prescribing information. However, the agency found that some advanced patients continued to use the medication despite these restrictions.
The agency emphasized the need for frequent liver testing in patients taking Ocaliva to monitor for worsening liver function, the release said.
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