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FDA Issues Warning for Ocaliva


Washington, DC: The US Food and Drug Administration (FDA) has issued a warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death.

According to the FDA warning , some patients are receiving excessive dosing, particularly a higher frequency of dosing than is recommended in the drug label for them.

Ocaliva may also be associated with liver injury in some patients with mild disease who are receiving the correct dose. The recommended dosing and monitoring for patients on Ocaliva are described in the current drug label.

Ocaliva is used to treat a rare, chronic liver disease known as primary biliary cholangitis (PBC). PBC causes the bile ducts in the liver to become inflamed, damaged and destroyed. This causes bile, a fluid that helps in digestion, to build up in the liver. This build-up damages the liver over time, eventually causing it to lose its ability to function. Ocaliva has been shown to improve a certain blood test that measures liver problems.

The FDA notes in its warning letter that the following symptoms may be signs of liver injury:

New or worsening fatigue
Diarrhea
Weight loss
Abdominal pain
Decreased appetite
Nausea and vomiting
Change in behavior or confusion
Vague symptoms such as anxiety or unease
Abdominal swelling
Yellow eyes or skin
Bloody stools



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Published on Sep-21-17


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