Ocaliva: Serious Liver Injury
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Intercept Pharmaceuticals Inc.’s Ocaliva (obeticholic acid) was approved by the FDA in May 2016 for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Since being on the market here in the US, liver related Ocaliva side effects have drawn scrutiny from the FDA on several occasions.
First, in September 2017, the FDA released a Drug Safety Communication warning of serious liver injury caused by Ocaliva, particularly when the incorrect dosage was given to the patient.
Next, in February 2018, we had this update to the earlier Drug Safety Communication: “FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease“.
Lastly, in May 2020, the FDA started an investigation of Ocaliva side effects involving unspecified “liver disorders”. This ongoing FDA Ocaliva safety evaluation is expected to take about 12 months to complete.
The following side effects may be caused by Ocaliva:
- Liver Injury
- Liver Failure
- Drug-Induced Hepatitis
- Hepatic Failure
- Hepatic Necrosis
- Portal Hypertension
- Hepatorenal Syndrome
We are currently investigating cases of these Ocaliva side effects as possible drug injury lawsuits filed for patients against the responsible drug company — and not your doctor.
We encourage you to submit a Drug Injury Law Case Review – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible drug injury case. Either way, you will get Mr. Lamb’s impressions — not an intake person, a paralegal, nor some other lawyer — about your case based on his many years of experience.
Most Recent Article About This Drug
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:
To read more of this article, click below:
[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]
Earlier articles by attorney Tom Lamb on the Side Effects Blog: