Ocaliva Recall Issued Due to Liver Injury Risks

Intercept’s decision to remove Ocaliva from the market comes after the FDA issued multiple liver injury warnings and rejected full approval.

The manufacturers of the liver disease drug Ocaliva say they are pulling it from the market at the request of federal regulators, who no longer believe the drug’s benefits outweigh the potential side effects that users may experience.

Intercept Pharmaceuticals, Inc. announced the Ocaliva recall in a press release issued on September 11, indicating the market removal came at the behest of the U.S. Food and Drug Administration (FDA), noting that the agency has placed a hold on all Ocaliva clinical trials.

Ocaliva (obeticholic acid) is an Intercept Pharmaceuticals drug approved for the treatment of primary biliary cholangitis (PBC), a chronic, rare, autoimmune disease that destroys the liver’s bile ducts over time. The ducts become inflamed and eventually collapse, causing liver damage that can eventually result in cirrhosis.

It is estimated that roughly 9,000 individuals across the U.S. are diagnosed with primary biliary cholangitis, with the disease predominantly affecting middle-aged women.

The FDA approved Ocaliva through its accelerated approval program in 2016, 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. However, once the drug was on the market, postmarketing clinical trials led to multiple warnings regarding the potential for serious liver injury among Ocaliva users with PBC.

In December 2024, the FDA issued an Ocaliva drug safety communication, warning that the very patients who the drug was designed to treat may face serious liver injury risks from Ocalivia, including an increased likelihood of death or needing a liver transplant.

The FDA’s drug safety alert marked the latest in a series of Ocaliva warnings dating back to 2017, when the agency first flagged serious liver injury risks. In 2018, the FDA required a black box warning, and by May 2021, it issued a third alert urging doctors to strictly follow dosing guidelines.

In November 2024, Intercept announced that the FDA had decided against giving Ocaliva full approval, following a vote against the drug by an FDA science advisory committee. However, Intercept still claims the drug was beneficial.

“While our view of OCALIVA’s benefit-risk profile differs from FDA’s, we respect its request and have made this difficult decision to provide clear guidance for patients and prescribers.”

– Vivek Devaraj, Intercept’s U.S. president.

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.

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