Ocaliva (obeticholic acid) was a prescription drug for primary biliary cholangitis, or PBC. FDA reported serious liver injury, including liver transplant and death, in Ocaliva patients without cirrhosis.
Intercept Pharmaceuticals, a subsidiary of Alfasigma, announced a voluntary U.S. market withdrawal at the request of FDA on September 11, 2025. Ocaliva was not recalled. Patients should talk to their doctor and should not stop the medicine on their own.
As of October 2026, no lawsuit or MDL names Ocaliva or Intercept Pharmaceuticals. The FDA figures on this page are regulator findings and not lawsuit allegations.
- Case or litigation name: No named case
- Defendants: None named
- Court and docket number, when available: No filed case
- MDL number, judge, and case count, when an MDL exists: No MDL
- Filing date: No filing yet
- Main allegations: FDA-documented serious liver injury, including liver transplant and death, in Ocaliva patients without cirrhosis (a regulator finding and not a complaint)
- Products or people involved: Ocaliva (obeticholic acid) patients treated for primary biliary cholangitis
Table Of Contents
Latest Ocaliva Lawsuit Updates
September 11, 2025: Intercept Withdraws Ocaliva from the U.S. Market
Intercept Pharmaceuticals announced it would withdraw Ocaliva from the U.S. market. It acted after a request from the FDA, as pharmaphorum reported [1].
The FDA also placed a clinical hold on all Intercept clinical trials under a U.S. IND involving obeticholic acid.
December 12, 2024: FDA Issues a Drug Safety Communication
The FDA issued a Drug Safety Communication on serious liver injury in Ocaliva patients without cirrhosis. Some cases ended in liver transplant [2].
The agency said the risk was notably higher for patients on Ocaliva than for those on a placebo. It urged frequent liver test monitoring.
November 12, 2024: FDA Issues a Complete Response Letter
The FDA issued a Complete Response Letter on Intercept’s supplemental New Drug Application for Ocaliva in PBC, as HCPLive reported [3]. The agency said it could not approve the application in its current form.
May 26, 2021: FDA Restricts Ocaliva Use in Advanced Cirrhosis
The FDA restricted Ocaliva use in PBC patients with advanced cirrhosis. It said the limit was due to the risk of serious liver injury. FDA added a new Contraindication to the Ocaliva prescribing information and the patient Medication Guide.
What Is Primary Biliary Cholangitis?
According to NIDDK, primary biliary cholangitis is a chronic disease. The small bile ducts in the liver become injured and inflamed and are eventually destroyed [4].
When there are no bile ducts, bile builds up and causes liver damage. Ocaliva was a prescription medicine for this condition.
Who May Be Affected?
Adults with primary biliary cholangitis who were prescribed Ocaliva may be affected. FDA approved the drug in May 2016. It was for patients who had not responded well enough to ursodeoxycholic acid.
FDA said some patients with advanced cirrhosis kept taking Ocaliva after the 2021 limits. An individual legal review decides whether a person qualifies.
Reported Injuries or Damages
The figures below come from the regulator. They are not allegations in a lawsuit. The FDA communication of December 12, 2024 describes a postmarket trial.
In that trial, 7 of 81 who received Ocaliva needed a liver transplant. That compares with 1 of 68 patients who received placebo.
Four more Ocaliva patients died, compared with one patient on placebo. FDA reported a hazard ratio of 4.77 (95% confidence interval: 1.03, 22.09). These findings do not prove that Ocaliva caused every case of liver injury.
Recall and Regulatory Background
Ocaliva was not recalled. Intercept withdrew it voluntarily from the U.S. market at the request of FDA, as WebMD reports [5].
Earlier FDA warnings came in September 2017, about serious liver injury with incorrect dosing, and in February 2018, with a Boxed Warning. The 2021 restriction and the 2024 communication followed.
Evidence to Preserve
Keep any record that shows you took Ocaliva and what happened to your liver afterward. Store copies in one place:
- Prescription and pharmacy records showing Ocaliva use and dates
- Medical records and liver test results
- Records of liver injury, transplant evaluation or hospital stays
- Notes or photos of your symptoms
- Messages with doctors, Intercept patient services and insurers
- The Ocaliva Medication Guide or packaging
Do not throw anything away until a lawyer or doctor says it is safe. Small papers can help show when you took it and what came next.
Filing Deadlines
Filing deadlines come from state law. They vary with where you live and with the date your injury and its diagnosis happened.
A late filing can end a claim for Ocaliva liver injury, even when the facts behind it are strong and well documented.
Speak with a lawyer promptly about which deadline applies to your situation, because the time to act may already be running.
Frequently Asked Questions
What Does the Research Say About Ocaliva Liver Injury?
The research on Ocaliva liver injury includes FDA’s review of 20 cases between May 26, 2021, and September 18, 2024. They involved 7 liver transplants, 8 evaluations or listings for transplant and 6 liver-related deaths. FDA could not judge if use was proper in most cases.
Is There an Ocaliva Lawsuit?
There is no verified Ocaliva product-liability lawsuit or MDL. The FDA safety communication and the voluntary market withdrawal are actions taken by the regulator and by the company, not court filings.
Why Was Ocaliva Taken Off the Market?
Ocaliva was taken off the market at FDA’s request. Intercept said its view of the benefit-risk profile differs from FDA’s and that the evidence supports use for appropriate patients. That is a company statement and not an FDA finding.
What Should I Do If I Took Ocaliva?
If you took Ocaliva, talk to your health care professional about the safety risk and other treatments. Do not stop the medicine on your own. You can report side effects to FDA MedWatch.
What Symptoms Mean Ocaliva Liver Injury Is Getting Worse?
Symptoms that may mean Ocaliva liver injury is getting worse include a swollen belly, yellow eyes or skin, bloody or black stools and confusion. FDA says to contact a health care professional right away if any of these appear.
Are There Other Treatments for PBC After Ocaliva?
Other treatments for PBC after Ocaliva include elafibranor (Iqirvo) and seladelpar (Livdelzi). FDA granted both accelerated approvals in 2024. Your doctor can explain whether either one suits you.
References
- https://pharmaphorum.com/news/intercept-pulls-ocaliva-market-us
- https://www.fda.gov/drugs/drug-safety-and-availability/serious-liver-injury-being-observed-patients-without-cirrhosis-taking-ocaliva-obeticholic-acid-treat
- https://www.hcplive.com/view/intercept-voluntarily-withdrawals-obeticholic-acid-ocaliva-for-pbc-from-us-market
- https://www.niddk.nih.gov/health-information/liver-disease/primary-biliary-cholangitis
- https://www.webmd.com/drugs/updates/ocaliva-pulled-us-market