Ocaliva Lawsuit: Serious Liver Injury Risks in PBC Patients

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Ocaliva Lawsuit: Serious Liver Injury Risks in PBC Patients

Pittman, Dutton, Hellums, Bradley & Mann, P.C. is investigating claims on behalf of patients who suffered liver complications after taking Ocaliva (obeticholic acid). The U.S. Food and Drug Administration (FDA) has issued an urgent safety warning after identifying reports of serious and potentially fatal liver injury in patients treated with Ocaliva for primary biliary cholangitis (PBC)—particularly among those without cirrhosis.

If you or a loved one developed liver failure, required a transplant, or suffered other serious complications while taking Ocaliva, you may be eligible for financial compensation.

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What Is Ocaliva?

Ocaliva (obeticholic acid) is a prescription medication approved to treat primary biliary cholangitis, a rare autoimmune disease that damages bile ducts in the liver. It works by activating the farnesoid X receptor (FXR), which helps regulate bile acid production and flow.

Doctors typically prescribe Ocaliva for adults who do not respond adequately to ursodeoxycholic acid (UDCA) or cannot tolerate UDCA.

While Ocaliva can help reduce certain liver enzyme levels, new clinical data suggests that in some patients—particularly those without cirrhosis—it may worsen liver function rather than improve it.

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FDA Safety Warning

The FDA issued a post-market safety communication after reviewing data from a clinical trial showing that Ocaliva users faced increased rates of liver failure, transplant, and death compared to those taking a placebo. The agency now warns physicians to closely monitor patients’ liver function and to discontinue the drug if there are any signs of liver deterioration.

The FDA’s advisory underscores the importance of frequent testing and prompt medical attention for symptoms such as:

• Yellowing of the skin or eyes (jaundice)
• Fatigue or weakness
• Abdominal pain or swelling
• Nausea or loss of appetite

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What Is Primary Biliary Cholangitis (PBC)?

Primary Biliary Cholangitis is a chronic, progressive autoimmune liver disease that primarily affects women between the ages of 35 and 70. It causes inflammation and gradual destruction of the small bile ducts within the liver. As bile builds up, it can lead to scarring (cirrhosis), liver failure, and severe complications.
Early management is critical, and medications must be carefully monitored to avoid additional liver damage.

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Legal Action Against Ocaliva’s Manufacturer

Drug manufacturers have a legal duty to ensure their products are safe, properly tested, and accompanied by adequate warnings. If Ocaliva’s manufacturer failed to fully disclose the risks of severe liver injury or failed to protect patients through sufficient safety monitoring, it may be held legally liable for resulting harm.

Our firm is reviewing cases where patients prescribed Ocaliva experienced:

• Liver failure or liver injury
• Hospitalization or transplant
• Worsening PBC symptoms
• Severe fatigue or jaundice following use

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How Pittman, Dutton, Hellums, Bradley & Mann, P.C. Can Help

Our attorneys have decades of experience representing individuals injured by dangerous and defective drugs. We work nationwide to hold pharmaceutical companies accountable for negligence and product safety failures.

If you or a loved one took Ocaliva and suffered liver damage or other serious health complications, you may be entitled to compensation for:

• Medical expenses and future care
• Pain and suffering
• Lost wages or earning capacity
• Wrongful death damages (for families of deceased patients)

We offer free, confidential case evaluations, and you pay nothing unless we recover compensation for you.

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Contact Us Today

To learn more about your rights and whether you qualify for an Ocaliva lawsuit, call (205) 322-8880 or fill out our secure online case evaluation form. Your health and safety should never be compromised by a dangerous medication. Let our firm help you pursue justice and hold those responsible accountable.

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