Request Legal Help Now - Free


FDA Issues Boxed Warning for Ocaliva

Washington, DC: UPDATE Further to information issued by the US Food and Drug Administration through a MedWatch safety alert for liver disease medicine Ocaliva (obeticholic acid) - Increased Risk of Serious Liver Injury, issued 09-21-2017, a Boxed Warning has been added to the product under the agency’s guidance.

The original warning stated that Ocaliva is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death.

Ocaliva is used to treat a rare, chronic liver disease known as primary biliary cholangitis (PBC). PBC causes the bile ducts in the liver to become inflamed, damaged and destroyed. This causes bile, a fluid that helps in digestion, to build up in the liver. This build-up damages the liver over time, eventually causing it to lose its ability to function. Ocaliva has been shown to improve a certain blood test that measures liver problems.

To ensure correct dosing and reduce the risk of liver problems, FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva. The FDA is also requiring a Medication Guide for patients to inform them about this issue.

As a condition of approval, FDA required the manufacturer of Ocaliva, Intercept Pharmaceuticals, to continue studying the medicine in patients with advanced PBC. These clinical trials are currently ongoing and FDA expects to receive results in 2023.

The FDA will continue to monitor this medicine and will update the public if new information becomes available.

The FDA notes in its 2017 warning letter that the following symptoms may be signs of liver injury:

New or worsening fatigue
Weight loss
Abdominal pain
Decreased appetite
Nausea and vomiting
Change in behavior or confusion
Vague symptoms such as anxiety or unease
Abdominal swelling
Yellow eyes or skin
Bloody stools

Legal Help

If you or a loved one has suffered similar damages or injuries, please fill in our form and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Last updated on


Posted by

NASDAQ: ICPT Shareholder Notice: Lawsuit Alleges Securities Laws Violations by Intercept Pharmaceuticals Inc. Intercept issued letter warning physicians against overdosing patients with Ocaliva (obeticholic acid), the Company's treatment for primary biliary cholangitis ("PBC"), advising them that the drug has been tied to liver injuries and death among patients suffering from PBC.

The plaintiff claims that between May 31, 2016, and September 20, 2017, the Defendants made false and/or misleading statements and/or failed to disclose that Ocaliva entailed undisclosed safety risks, including death, to patients suffering from PBC, and that as a result of the foregoing, Intercept's public statements were materially false and misleading at all relevant times.

Seriously!! there are patients who have been misled, lost their lives, or suffered injury from this drug where is the justice for the patients.

Posted by

I had been participating in the clinical drug trial for Obetacholic Acid (Ocaliva) through Intercept Pharmaceuticals from January 29, 2016 through April 19th of this year when I opted out of the study program per my choice. After I opted out of the research program I decided to research the study I was in. I found the website and looked up the research study I was participating in and looked at the criteria sure I met all the inclusion criteria however in looking at the exclusion criteria: it clearly states history or presence of other concomitant liver disease including definite autoimmune liver disease or overlap.

I was diagnosed in 2014 with Primary Biliary Cholangitis formerly known as Primary Biliary Cirrhosis. The biopsy at the time of my diagnosis indicated PBC with possible autoimmune hepatitis overlap. I was started on treatment for the (PBC) which was Ursodiol it was the only FDA approved treatment at the time of my diagnosis. During the time I participated in the clinical study it was never a consideration to treat for the autoimmune hepatitis overlap even after my insistence to consider the possibility there was no due diligence to investigate all probable causes before they came to any conclusion especially since there was evidenced based possibility.

On September 21st of this year the FDA issued a warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. These patients are receiving excessive dosing, particularly a higher frequency of dosing than is recommended in the drug label for them. Which I find to be quite interesting considering when I started in the research program the initial dose I received was 5mg daily for three months and at the three month mark the dose was increased to 10mg daily until I opted out. There was noted significant increase noted in LFT tests from baseline.
After I opted out of the study program I requested to be referred to a new hepatologist and had another liver biopsy on August 28th of this year which the results showed worsening liver injury with chronic portal and lobular hepatitis with moderate activity. There was definite Autoimmune hepatitis overlap component present.

One could question the ethics of subject recruitment regarding pharmaceutical clinical drug trials and the exploitation of the participants on the front end as well as the back end. I am aware that pharmaceutical drug trials must meet a certain number of participants before the trial can start. I believe I was one of those numbers they needed and chose not to acknowledge the obvious exclusion criteria because in acknowledging the autoimmune hepatitis overlap my participation would not have been possible. I see this as an act or omission in which treatment provided or not provided falls below the accepted standard of practice I do not believe it was an error or oversight.

There are really a lot of questions one could ask and debate. One could clearly question the deviation in protocol as violation that presented unreasonable risks by failure to comply with protocol therefore considered a failure to protect the rights, safety, and welfare of me the subject because of the non-compliance exposed me the subject to unreasonable risks. Not to mention the disheartening probability that this scenario may be more common than one knows the perfect storm for a bad drug.

In this incident since the research study I participated in was for evaluating the effect of Obeticholic Acid on Clinical outcome in subjects with (PBC) with having the autoimmune hepatitis component that presents the concern of data information collected from me and how many others were possibly accepted with a contaminant component present which I find to be a legitimate question of concern as the data outcome would be faulty. So, one could ask how could the clinical outcome be accurate with conclusion for treatment of (PBC) with Odeticholic Acid. How could one be confident in the positive effects of this treatment regime which was recently fast tracked and approved for the treatment of (PBC). Which could raise another question since the pharmaceutical company pushed to fast track the drug was there deviation in protocol to accomplish this.


Fields marked * are mandatory. Please read our comment guidelines before posting.


Note: Your name will be published with your comment.

*Email Address:

Your email will only be used if a response is needed.
*Your Comment:

Are you the defendant or a subject matter expert on this topic with an opposing viewpoint? We'd love to hear your comments here as well, or if you'd like to contact us for an interview please submit your details here.

Request Legal Help Now! - Free