Written by Rafsana Writu
What is Primary Biliary Cholangitis?
Ocaliva was sold by Intercept Pharmaceuticals for the treatment of primary biliary cholangitis (PBC), an autoimmune liver disease[iii] that damages the bile ducts in your liver, so bile can’t flow through them. The disease causes inflammation on its own building up bile ducts in your liver which ultimately leads to scaring of the liver. Ocaliva is often used to improve bile flow and slow down the causes of liver damage.
Ocaliva is Withdrawn for Sale in the United States
The drug was removed for marketing by the European Commission in August, 2024[iv]. There was concern that the drug did not have the benefits expected in real world testing. The FDA notified users in December 2024 that cases of severe liver injury were being reported[v]. In September 2025, Intercept Pharmaceuticals announced a voluntary withdrawal of the drug from the United States market[vi].
Cause and Risk Factors of Primary Biliary Cholangitis
The cause of the disease is unknown. However, the primary biliary cholangitis can be triggered by environmental and genetic factors where the body turns against its own cells. Due to the lack of noticeable symptoms in the beginning stage, patients are often diagnosed while doing blood tests for other health related issues or during routine check-up. The chronic and progressive nature can take over 5 to 20 years for symptoms to develop but in the end, it may cause liver failure. Women are also more likely than men to develop primary biliary cholangitis.
Some Common Primary Biliary Cholangitis Symptoms
It often starts with subtle early symptoms including:
- Intense itchy skin
- Profound fatigue
As the disease progresses, more signs of liver damage start to appear, such as:
- Jaundice (yellow skin/eyes)
- Upper abdominal pain
- Darkening of the skin (hyperpigmentation)
- Easy bruising/bleeding
- Buildup of fluid
- Osteoporosis
Ocaliva: In Treating the Primary Biliary Cholangitis Disease
Ocaliva is designed to improve bile flow and reduce liver damage in patients diagnosed with Primary Biliary Cholangitis (PBC). However, according to the FDA Adverse Event Reporting System Database, there have been several cases of serious liver injury associated with Ocaliva, leading to liver decompensation or liver failure. As a result, the FDA has restricted the use of Ocaliva in PBC patients with advanced cirrhosis due to the risk of significant harm.
Guidelines to Further Protect Patients:
- Regular monitoring and continuous follow up with health care provider
- Understanding of symptoms
- Stay updated with information regarding PBC
Litigation and Settlements: Plan Your Next Step
As more reports of liver injuries linked to Ocaliva have surfaced, legal action may soon emerge. Collecting information can only help build your case stronger.
Here is what patients should know when moving onto legal claims:
Legal Options
If you or a loved one experienced a liver injury from Ocaliva and are exploring settlement options, it’s important to consult with experienced professionals who specialize in medical cases and can help you navigate the process and pursue the best possible outcome.
Evidence Collection
It is important to gather medical records that include a detailed history of treatment related to liver injury. Keeping track of symptoms experienced, along with any written documents from health care providers regarding effects related to Ocaliva can create a strong case.
Compensation Consideration
It is important to ensure that patients receive fair compensation based on the harm caused by the injury. Negotiating the right settlement can help cover:
- Medical bills
- Lost income
- Pain and suffering
- Any other damage suffered
For further assistance, please contact our firm to arrange a consultation with an experienced legal professional who can evaluate your individual circumstances and work toward the best possible outcome for you.
Sources
[i] https://www.webmd.com/drugs/updates/ocaliva-pulled-us-market
[ii] https://www.interceptpharma.com/about-us/ocaliva-withdrawal-faq/
[iii] https://www.mayoclinic.org/diseases-conditions/primary-biliary-cholangitis/symptoms-causes/syc-20376874
[iv] https://www.ema.europa.eu/en/news/ema-recommends-revoking-conditional-marketing-authorisation-ocaliva
[v] https://www.fda.gov/drugs/drug-safety-and-availability/serious-liver-injury-being-observed-patients-without-cirrhosis-taking-ocaliva-obeticholic-acid-treat
[vi] https://www.interceptpharma.com/about-us/ocaliva-withdrawal-faq/
