Obeticholic acid (Ocaliva), a medication used to treat primary biliary cholangitis (PBC), has been fully withdrawn from the U.S. market. Intercept Pharmaceuticals announced the voluntary withdrawal after a request from the U.S. Food and Drug Administration (FDA). Additionally, the FDA has put a hold on clinical trials in the U.S. involving obeticholic acid.

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This decision comes after new FDA safety data showed that obeticholic acid may cause serious liver injury — including cases requiring a liver transplant — even in people without cirrhosis (late-stage liver disease where scar tissue replaces healthy liver tissue).

Why Is Ocaliva Being Withdrawn?

Obeticholic acid was granted accelerated FDA approval in 2016 for people with PBC who did not respond well enough to ursodiol (also called ursodeoxycholic acid, or UDCA). While it helped lower alkaline phosphatase (ALP) levels — a marker of liver health — its long-term benefits were still being studied.

Recent safety reviews found:

• People without cirrhosis who took obeticholic acid had higher risks of liver injury, transplant, and even death compared with those taking a placebo (inactive treatment).
• Some people continued to receive obeticholic acid despite earlier restrictions on its use for advanced cirrhosis, leading to preventable harm.

In addition to safety concerns, confirmatory trials required by the FDA did not provide clear evidence that obeticholic acid improves survival or reduces serious liver complications.

Because both safety and efficacy requirements were not met, the FDA asked Intercept to withdraw the medication.

What This Means if You’re Taking Ocaliva

If you’re currently prescribed obeticholic acid, do not stop taking it on your own. Intercept and the FDA recommend talking to your liver specialist or healthcare professional as soon as possible before making any changes. Your doctor may recommend undergoing additional liver function monitoring, switching to another treatment, or adjusting your care plan.

Additionally, they recommend that you report any new or worsening symptoms as soon as possible. These symptoms may include:

• Yellowing of the eyes or skin
• Swelling in the belly
• Loss of appetite or nausea
• Coughing up or vomiting blood
• Confusion, slurred speech, or changes in mental status

Intercept is offering support through its Interconnect Patient Services online or at 844-622-4278 to help guide people through the transition.

Next Steps in PBC Treatment

Although obeticholic acid will no longer be available, there are other treatment options for PBC. UDCA remains the first-line therapy. Newer drugs, such as elafibranor (Iqirvo) and seladelpar (Livdelzi), have been approved in the U.S. as options for people who don’t respond adequately to UDCA alone or who can’t tolerate it.

Other approaches, like fibrates and ongoing research into additional medicines, may also provide alternatives. In advanced cases, a liver transplant can restore liver function.

The withdrawal of obeticholic acid is a significant change, but it does not mean people with PBC are out of options. Work closely with your healthcare provider to discuss the best path forward for your individual situation.

Learn more about treatment options for PBC.

Talk With Others Who Understand

On myPBCteam, people share their experiences with PBC, get advice, and find support from others who understand.

Have you experienced switching medications for PBC? Let others know in the comments below.