Ocaliva (Obeticholic Acid) Linked to Increased Risk of Liver Failure in PBC Patients Without Cirrhosis

FDA Warning:
The FDA has issued a safety alert highlighting the risk of severe liver injury in patients with primary biliary cholangitis (PBC) without cirrhosis who are treated with Ocaliva (obeticholic acid)3 4.

Liver Injury Risk:
Postmarket clinical trial data show that PBC patients without cirrhosis who received Ocaliva had a higher risk of liver transplant and death compared to those who received a placebo. Specifically, 7 out of 81 patients on Ocaliva needed a liver transplant, and 4 died, compared to 1 out of 68 patients on placebo who needed a transplant and 1 who died3 4.

Previous Restrictions:
In 2021, the FDA restricted the use of Ocaliva in PBC patients with advanced cirrhosis due to the risk of serious liver injury, adding a new contraindication to the prescribing information1 4.

Monitoring Importance:
Continuous monitoring of liver function is crucial during Ocaliva treatment, and therapy should be discontinued if there is evidence of hepatic decompensation3 4.

Common Side Effects:
Common side effects of Ocaliva include pruritus (itching), fatigue, stomach pain, rash, joint pain, and dizziness. However, the drug also carries a risk of severe liver injury, which can lead to liver transplant or death2 5.

Clinical Trial Findings:
The FDA’s review of postmarket clinical trial data identified cases of serious liver injury among PBC patients without cirrhosis who were treated with Ocaliva, emphasizing the need for careful patient selection and monitoring3 4.