Ocaliva Side Effects Linked to Severe Liver Injuries in Some Cirrhosis Patients: FDA Warning

Federal drug regulators indicate they will restrict the use of the liver disease medication Ocaliva, due to a risk that side effects may cause liver failure for some patients suffering from cirrhosis.

In a drug safety communication issued on May 26, the FDA announced the new restrictions on Ocaliva, which will contraindicate the drug’s use among patients with primary biliary cholangitis (PBC), with advanced cirrhosis of the liver.

PBC is a chronic, rare, autoimmune disease with destroys the liver’s bile ducts over time. The ducts become inflamed and eventually collapse, causing liver damage and can eventually result in cirrhosis.

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Ocaliva (obeticholic acid) is an Intercept Pharmaceuticals drug approved in 2016 for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) for adults with an inadequate response to UDCA alone, and for those who are unable to tolerate UDCA. It was approved under accelerated conditions through the orphan drug program, meaning it did not go through the full, rigorous review drugs normally are required to undergo.

However, the FDA now warns that some PBC patients, particularly those with advanced cirrhosis of the liver, suffered liver failure after taking the drug. In some cases, patients required a liver transplant as a result of Ocaliva side effects, the agency warns.

“In the five years since Ocaliva’s accelerated approval, FDA identified 25 cases of serious liver injury leading to liver decompensation or liver failure associated with Ocaliva in PBC patients with cirrhosis, both in those without clinical signs of cirrhosis (compensated) or in those with clinical signs of cirrhosis (decompensated),” the agency warns. “Many of these PBC patients had advanced cirrhosis before starting Ocaliva.”

The new contraindication warns Ocaliva should not be used in patients with PBC and advanced cirrhosis. The FDA also added the information to a boxed warning on the prescribing information. It is the strongest label warning the agency can require a drug to carry. However, the FDA is not issuing an Ocaliva recall, noting that the agency still believes the benefits outweigh the risks for PBC patients without an advanced cirrhosis diagnosis.

The FDA recommends patients with PBC who also have cirrhosis and are taking Ocaliva should talk to their doctor about the new warnings, and should contact their prescriber immediately if they develop worsening signs of liver injury or advanced cirrhosis. Symptoms could include:

  • Nausea
  • Vomiting
  • Diarrhea
  • Jaundice
  • Scleral icterus
  • Dark urine.

Health care providers are urged to determine whether a patient with PBC has advanced cirrhosis before starting them on Ocaliva, routinely monitor patients on Ocaliva for progression of PBC, and permanently discontinue use of the drug in patients who progress to advanced cirrhosis. They should also monitor patients for clinically significant acute-or-chronic liver disease.

The FDA encourages doctors and patients to report any adverse events linked to Ocaliva use to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.


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