After Being Pulled from the Market, Liver Drug Ocaliva Could Soon Face Lawsuits
Following its withdrawal from the U.S. market last month, Ocaliva could soon be the subject of new lawsuits. The drug, which was made by Intercept Pharmaceuticals, had been used to treat primary biliary cholangitis (PBC), a rare and serious condition that can lead to severe liver damage.
Now, lawyers are investigating potential cases for people who may have been harmed by the drug.
Even before its withdrawal, Ocaliva had faced obstacles. In 2021, the Food and Drug Administration restricted the drug’s use after determining that it could cause “serious harm” to people who already had advanced liver scarring. Those concerns were later extended to patients who didn’t have scarring.
The FDA then went on to eventually request that the drug be pulled from the market entirely, a step that Intercept voluntarily took in September. Ocaliva was fully withdrawn by mid-November.
Ocaliva Lawsuits May Involve Liver Damage, Failure and Transplants
Potential Ocaliva lawsuits could focus on claims that the drug caused serious injuries to the liver.
Lawyers are currently looking into cases of people who took Ocaliva and later developed liver failure, required a liver transplant or suffered serious liver injuries. Some of the symptoms of these conditions include yellow skin, a swollen belly and vomiting blood.
The FDA had previously warned patients to talk with their doctors about the risks and benefits of taking Ocaliva and to watch for symptoms of liver injury.
Despite Fast-Tracked Approval, Problems with Ocaliva Persisted
Ocaliva first hit the market in 2016 as part of the FDA’s accelerated approval process. It provided a new option for patients with PBC who hadn’t received relief from other existing treatments.
“OCALIVA has played a meaningful role in the treatment landscape for patients living with this rare disease,” Intercept Pharmaceuticals said in a press release regarding the withdrawal.
But in the following years, issues began to emerge. In 2021, the FDA restricted use of the drug among people who had advanced liver scarring after determining that the drug could cause serious liver injury in those patients.
A few years later, the FDA found that some people taking Ocaliva had developed severe liver damage, even if they had no prior scarring. The risk of liver damage was determined to be notably higher among people taking the drug than those receiving a placebo.
The agency then directed doctors to monitor the liver function of people taking Ocaliva but noted that “it is not clear if this monitoring will be sufficient to address the risk of serious liver injury.”
By the end of 2024, the drug had been removed from the European market over similar concerns.
Ocaliva was then pulled from the U.S. market less than a year later. It is unclear how many patients may have been impacted by these potential issues.
Consult with an Ocaliva liver damage lawyer to learn more about your legal options.
