Ocaliva Lawsuits Over Failure To Warn About Liver Injury Problems May Follow Market Withdrawal

More than 6,600 adverse event reports were linked to Ocaliva side effects, including at least 367 patient deaths, before the manufacturer decided to remove the drug from the market earlier this year.

In the wake of an Ocaliva recall issued in September due to serious liver injury risks, many former users and their families are now questioning whether the drug’s manufacturers adequately tested a medication that was intended to protect the liver, not harm it.

Ocaliva (obeticholic acid) was an Intercept Pharmaceuticals drug approved by the U.S. Food and Drug Administration (FDA) in 2016 for the treatment of primary biliary cholangitis (PBC), a rare autoimmune disease that slowly destroys the liver’s bile ducts. PBC causes the ducts to become inflamed and eventually collapse, leading to liver damage, which can eventually result in cirrhosis.

The FDA approved Ocaliva through its accelerated approval program, allowing the drug to be marketed for use in combination with ursodeoxycholic acid (UDCA) or as a second-line therapy for those who failed to adequately respond to UDCA alone, aiming to slow disease progression and improve liver function over time. 

However, problems with Ocaliva surfaced quickly. The FDA first warned of Ocaliva dosing errors in September 2017, then issued a black box warning in February 2018 that tightened dosing instructions, added new monitoring requirements, and expanded safety warnings.

Roughly a year after an advisory panel voted against giving the drug full approval, the FDA decided not to grant Ocaliva permanent authorization. In December 2024, the agency warned that Ocaliva was linked to a 377% higher risk of liver transplant or death, citing 19 fatalities and 11 severe liver injuries reported within 18 months of its release.

Intercept Pharmaceuticals ultimately withdrew Ocaliva from the market in September, after federal regulators concluded that its risks outweighed its benefits, and it is now expected that individuals who suffered severe liver injuries will come forward to pursue Ocaliva lawsuits, claiming these injuries could have been prevented if the drug makers had properly tested the drug before putting it in circulation, or had provided adequate warnings to users and the medical community.

Ocaliva Dosing Instructions

Initial problems with Ocaliva were first attributed to confusion over dosing instructions. In eight deaths investigated by the FDA, seven involved patients whose PBC symptoms worsened after taking the drug. Many of these patients had moderate to severe liver impairment but were still prescribed 5 mg daily, a regimen that significantly exceeded safe limits.

For patients with reduced liver function, the recommended dosage was 10 mg twice weekly, or roughly 20 mg per week. Those taking 5 mg daily, however, were receiving 35 mg per week, nearly double the intended amount. This misdosing was linked to several severe liver injury cases and prompted the FDA’s first safety communications in 2017 and 2018.

Ocaliva Patient Deaths

However, the FDA later announced that postmarketing data showed a significantly increased risk of Ocaliva liver injury regardless of the dosing. The agency found that in a study of 81 Ocaliva patients considered to have a lower initial risk of liver injury, seven ultimately required a liver transplant, while a transplant was needed by only one of the 68 patients given a placebo.

Notably, that single placebo patient had switched to Ocaliva for two years before needing the transplant, suggesting Ocaliva side effects may have still played a role in the injury. Four Ocaliva patients ultimately died, compared to just one in the placebo group.

According to recent FDA Adverse Event Reporting System (FAERS) data, the agency has received at least 6,624 adverse event reports, with about 3,000 of those filed in the first couple years the drug was on the market. To date, the FDA has linked 367 deaths to Ocaliva adverse event reports.

Non-Responsive Ocaliva Patients Face Higher Risks

One of the most recent studies on Ocaliva side effects was published on September 22 in Alimentary Pharmacology and Therapeutics, where researchers from the U.K.’s National Institute for Health and Social Rare Research (NIHR) determined that patients who had a biochemical non-response, meaning their PBC did not react to the treatment, faced extremely high risks of Ocaliva liver injury and cirrhosis.

Looking at data from 336 patients who started using Ocaliva between August 2017 and 2019, the researchers found that 64 of those patients suffered clinical events over a four-year period. The researchers calculated that if a patient showed no biological response to the drug, meaning their PBC was not improving, they were:

• Four and a half times more likely to suffer a clinical event
• 20 times more likely to develop cirrhosis
• Twice as likely to develop hyperbilirubinaemia, which can cause jaundice

While the data indicated response rates did increase over time, researchers noted that was often too late. Ocaliva liver side effects and other factors led to a 45% discontinuation rate over those same four years, meaning many patients never got the opportunity for their bodies to adjust before quitting the medication.

Ocaliva Liver Injury Lawsuits Under Investigation

As mounting evidence links Ocaliva side effects to serious liver injury risks, Ocaliva injury lawyers are now investigating product liability claims against Intercept Pharmaceuticals for marketing the drug for PBC treatment and pushing it through the FDA’s accelerated approval process before it had been fully tested.

Ocaliva lawsuits are being reviewed for individuals who took the medication and later experienced liver injury, liver failure or death.

Claims are expected to allege that the manufacturer failed to warn the medical community and patients about the risks of Ocaliva liver injuries, while misleading the FDA about the drug’s safety.

Free case evaluations are available, and there are no fees unless a recovery is obtained.

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