Lack of Warnings in Current Ocaliva Drug Label for Some Serious Side Effects Involving Liver, Gallbladder, Bile Ducts


(Posted by Tom Lamb at


We are still wondering how the current FDA investigation of an Ocaliva safety signal — said to be involving a potential liver disorder risk — was able to fly below the radar for five months before first being reported in early October 2020. Remarkably, the first mention of this possible Ocaliva liver toxicity issue was found in a U.S. Securities and Exchange Commission (SEC) financial quarterly report filed by Intercept Pharmaceuticals, as discussed in our last article, “Current Ocaliva Liver Safety FDA Evaluation Started Back in May 2020“.

A few days after that FDA Ocaliva investigation “discovery” was made, we were provided some additional information about what types of hepatobiliary events (i.e., involving liver, gallbladder, bile ducts, or bile) might have given rise to this Ocaliva safety signal. From an October 13, 2020 news report, “Shedding light on Intercept’s opaque disclosure“, published by Evaluate Vantage, we get these details:

[The safety database Advera Health Analytics] which gets its data from the FDA’s FAERS adverse event reporting system and adjusts for a number of factors to add context and remove duplication, shows several active liver toxicity signals not already cited on Ocaliva’s label.

These include liver failure and portal hypertension, all derived from adverse event reporting from in-market use of Ocaliva for [treatment of a rare chronic liver disease, primary biliary cholangitis (PBC)]….

One caveat is that all of these issues could be related to the underlying disease, since PBC affects the liver, but the higher the [risk odds ratio (ROR)] the less likely it seems that this would explain away the adverse event seen.

For more details, we point out the Table titled “Most frequently reported adverse events for Ocaliva in the hepatobiliary system organ class” which is part of this recent Evaluate Vantage news report about the Ocaliva safety signal FDA investigation. Taken from that Table, here is a list of “serious” adverse events which were reported to the FDA but that are not “cited” on the current Ocaliva drug label:

  • Chronic hepatic failure
  • Portal hypertension
  • Hepatic failure
  • Hepatorenal syndrome
  • Autoimmune hepatitis

We are investigating possible Ocaliva drug injury lawsuits that would be filed against Intercept Pharmaceuticals, the responsible drug company, for patients who have been diagnosed with these serious possible Ocaliva side effects.

Of course, while we watch for findings from the FDA Ocaliva safety signal investigation, we will continue to monitor the medical and regulatory realms for significant developments regarding this Ocaliva liver toxicity issue. Medical & Legal Information About Drug Side Effects
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