Ocaliva Market Withdrawal To Take Final Effect on Nov. 14

Following the drug’s recall last month, the FDA has agreed to a transitional period that will give patients time to switch to another medication.

Users of the liver disease drug Ocaliva will have access to the recalled medication until November 14, after which it will no longer be available, according to the manufacturer.

In 2016, the U.S. Food and Drug Administration (FDA) granted approval to Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC), a chronic, rare autoimmune disease that destroys the liver’s bile ducts over time. PBC causes the ducts to become inflamed and eventually collapse, leading to liver damage that can eventually result in cirrhosis.

Ocaliva’s approval came through the FDA’s accelerated approval program and was meant to be used in combination with ursodeoxycholic acid (UDCA) or as a second-line therapy for those who have had an inadequate response to UDCA alone, aiming to slow disease progression and improve liver function over time. 

Ocaliva Liver Risks

Once Ocaliva was on the market, postmarketing data linked the drug to an increased risk of serious liver injuries.

In December 2024, the FDA issued an Ocaliva drug safety communication, warning that the very patients who the medication was designed to treat may face serious liver injury risks from it, including an increased likelihood of death or needing a liver transplant. That followed a series of Ocaliva liver warnings dating back to the drug’s approval, including a black box warning in February 2018 with updated dosing and monitoring instructions.

However, those changes and warnings were not enough, with the FDA deciding against granting Ocaliva full approval last year after one of the agency’s science advisory boards voted against it. FDA investigators determined that Ocaliva was linked to a 377% increased risk of death or the need for a liver transplant.

Last month, Intercept Pharmaceuticals, the manufacturer, announced an Ocaliva recall indicating federal regulators had determined the drug’s benefits did not outweigh its risks.

The manufacturer has since released an FAQ on the Ocaliva recall, to address questions current users of the drug may have, as well as its availability going forward.

The FAQ indicates that the FDA has approved a transitional period, during which Ocaliva will remain available for current patients, giving them time to switch to an alternative therapy.

This transition period will end on November 14, 2025, after which Ocaliva will no longer be commercially available in the United States.

According to Intercept, patients prescribed Ocaliva should consult with their healthcare providers before making any medication changes. The company indicates it will provide additional information as it works through the transition process with the FDA.

Patients with questions can contact Intercept’s Patient Support Services (Interconnect) at 1-844-622-4278. Healthcare professionals should direct questions to Intercept Medical Information at medinfo@interceptpharma.com or call 1-844-782-4278.

For former users left with liver injuries, lawyers are now investigating the potential for Ocaliva lawsuits, which may help obtain financial compensation from the drug makers, for failing to adequately warn about the potential side effects of Ocaliva.