In our last article, we reported on the current FDA investigation of an Ocaliva safety signal which, although it began in May 2020, only became public knowledge in October. The best we can tell, it is a possible Ocaliva liver toxicity issue that is the subject of this Ocaliva FDA investigation.
Now we have some additional information about some hepatobiliary events (i.e., involving liver, gallbladder, bile ducts, or bile) which 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.
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:
- Chronic hepatic failure
- Portal hypertension
- Hepatic failure
- Hepatorenal syndrome
- Autoimmune hepatitis
Of course, while we watch for findings from the FDA investigation of an Ocaliva safety signal, we will continue to monitor the medical and regulatory realms for significant developments regarding this Ocaliva liver toxicity issue.[View article in full at original source]