FDA Adds Black Box Warning to Ocaliva

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Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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On September 21, 2017,  the FDA issued a drug safety communication for the medication, Ocaliva. The communication highlighted the increased risk of serious liver injury due to being incorrectly dosed in some patients with moderate to severe decreases in liver function.

In response to this safety communication, on February 1st, the FDA added a boxed warning to Ocaliva to highlight the dosage issues.

What is Ocaliva indicated for?

Ocaliva is indicated for the treatment of primary biliary cholangitis (PBC), a chronic liver disease resulting from progressive destruction of the bile ducts in the liver. PCB primarily affects women, as approximately 1 in 1,000 women have this condition. Bile in your liver aids in the digestion of fat and fat-soluble vitamins. When the ducts are destroyed, bile builds up and can lead to inflammation and scarring.

What confusion has Ocaliva dosing caused?

Ocaliva continues to be incorrectly dosed daily instead of weekly, which has led to liver decompensation, liver failure, and death. Healthcare professionals should follow the Ocaliva dosing regimen in the drug label.

Contact your prescriber immediately if you develop any of the following symptoms that may be signs of worsening liver problems: stomach swelling, yellow eyes or skin, bloody or black stool, coughing or vomiting up blood, or mental changes.

Does the FDA require Intercept Pharmaceuticals to do anything else at this time?

Yes.  As a condition of approval, the FDA requires Intercept Pharmaceuticals to continue studying the medicine in patients with advanced PBC. 

These clinical trials are currently ongoing and FDA expects to receive results in 2023.

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