Texas Ocaliva Lawyer

After the FDA issued several warnings about Ocaliva side effects, including serious liver injury and deaths, it was pulled off the U.S. market by Intercept Pharmaceuticals.

Need a Texas Ocaliva Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you were diagnosed with liver damage after taking Ocaliva, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.

Ocaliva Recall

In September 2025, Intercept Pharmaceuticals announced that it would withdraw Ocaliva from the U.S. market and put all clinical trials on hold. The decision was made at the request of the FDA, according to Intercept, and came after a series of FDA warnings about serious liver injuries and death.

What is Ocaliva?

Ocaliva was a new type of medication for the treatment of Primary Biliary Cholangitis (PBC), a rare autoimmune disease that occurs when the immune system mistakenly attacks the small bile ducts in the liver. Over time, inflammation of the bile ducts can destroy them, which in turn causes severe liver damage. PBC is a long-term progressive disease that can ultimately cause liver failure or death.

How Does Ocaliva Work?

The only other treatment for PBC is a medication called ursodeoxycholic acid (UDCA), also known as ursodiol. It has been used for over 100 years to treat liver disease and gallstones.

Unlike this other medication, Ocaliva works by activating the farnesoid X receptor (FXR), which helps the body regulate bile acid levels by reducing the amount of bile acids, and increasing their flow out of the liver. This reduces the overall exposure to bile acids and damage.

FDA Orders Safety Studies After Fast-Track Approval

Ocaliva was fast-tracked through the FDA approval process in May 2016, giving patients earlier access to try a new medication for PBC. The FDA asked Intercept Pharmaceuticals to conduct safety studies to investigate Ocaliva side effects, as a condition of the quick approval.

FDA Warnings for Ocaliva Liver Side Effects

Ocaliva safety studies soon found evidence of liver side effects, which resulted in a series of FDA Drug Safety Communications and “Black Box” warning labels on the Prescribing Information for Ocaliva.

The FDA warnings for Ocaliva include:

September 2017: FDA warning that Ocaliva was “being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of liver injury and death.” The FDA also said it received reports of serious liver injuries associated with Ocaliva, including 19 reports of deaths.
February 2018: Another FDA warning about incorrect dosing for Ocaliva in patients with PBC, which increases the risk of serious liver injury or death. The FDA added a “Boxed Warning” about this risk.
May 2021: The FDA restricts the use of Ocaliva in patients with advanced cirrhosis due to the risk of serious liver injury. There were 25 reports of serious liver injury linked to Ocaliva, including some patients who had to have a liver transplant.
December 2024: The FDA warns about reports of patients without pre-existing cirrhosis of the liver who were diagnosed with a serious liver injury or died after taking Ocaliva.

Serious Side Effects of Ocaliva

Ocaliva has been linked to severe, life-threatening side effects, such as:

Serious Liver Damage
Hepatic Cirrhosis (Scarring of the Liver)
Liver Failure
Biliary Cirrhosis
Chronic Hepatic Failure
Liver Decompensation
Drug-Induced Liver Injury
Liver Transplant
Liver Transplant Rejection
Death

Signs & Symptoms of Liver Injury

Liver damage may not cause any symptoms in the early stages. The early symptoms can also be vague or easily mistaken for other conditions. These general symptoms include belly pain, nausea, loss of appetite, tiredness, weakness, light-headedness, and more.

There can also be severe signs of liver damage. The FDA urged patients on Ocaliva to seek medical attention immediately for symptoms of a serious liver injury, such as:

Swollen belly
Yellow eyes or skin (jaundice)
Black or bloody stools
Coughing up or vomiting blood
Mental status changes such as confusion, slurred speech, mood swings, changes in personality, or increased sleepiness or difficulty waking up

How Can an Ocaliva Lawsuit Help?

Our law firm is investigating cases for people who were injured by Ocaliva side effects in the liver, including new or worsening liver damage, liver failure, liver transplant, other complications, or death.

Ocaliva is a new medication and many patients hoped it would help prevent liver damage due to PBC. Instead, many of these patients tragically suffered serious liver injuries or died after taking Ocaliva.

Ocaliva was on the market for nearly a decade, and during this time, the FDA received dozens of reports of patients who were diagnosed with worsening PBC symptoms, liver failure, transplants, and deaths. Even so, Intercept Pharmaceuticals did not pull Ocaliva off the market until September 2025, and only after the FDA made a formal request.

Lawsuits for Failure To Warn About Side Effects

There is no excuse for selling a medication with serious, life-threatening side effects. Lawsuits involving people who were injured by prescription medications will typically accuse drug-makers of:

- - - Failing to adequately warn patients and doctors about the risk of side effects
    - Failing to recall a medication they knew was dangerous
    - Continuing to sell a medication, putting profits ahead of public safety
    - Every lawsuit is unique, but people who were injured generally argue that they never would have taken the medication if they had been fully warned about the risk of side effects.

How Much is My Lawsuit Worth?

Lawyers will fight for justice and financial compensation for their clients. This may result in a settlement or other payout. Lawsuits seek compensation for the victim’s pain and suffering, medical bills, long-term injuries, decreased quality of life, wrongful death, and more.

Need an Ocaliva Lawyer in Texas?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.