FDA Warns On Fatal Risk of Misdosing Ocaliva

Highlights

The FDA releases black box warning for the drug Ocaliva after the excessive dosing.
Incorrect dose of Ocaliva for a rare liver disease, increases the risk of liver injury and death. /
The drug manufacturer, Intercept Pharmaceuticals Inc has released prescribing information for Ocaliva to health care providers.

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.

Intercept gave healthcare providers prescribing information for Ocaliva and flagged reports of liver failure and deaths. Two weeks later, the FDA released a black box warning.

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‘The U.S. Food and Drug Administration warned that Intercept Pharmaceuticals Inc's drug Ocaliva was being incorrectly dosed in some patients with a rare liver disease, increasing the risk of liver injury and death.’

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A black box warning is the strictest warning by the FDA that appears on a prescription drug’s label, calling attention to serious or life-threatening risks of a drug.

Nineteen deaths and 11 cases of serious liver injury were associated with the use of Ocaliva, the FDA said. Some patients were receiving higher doses of the drug, particularly due to a higher frequency of dosing than recommended in the label, the agency added.

Ocaliva For Liver Disease

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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.

The FDA approved obeticholic acid in May 2016 to treat adults with PBC in combination with ursodeoxycholic acid (UDCA) when the latter drug falls short therapeutically, or by itself when adults can’t tolerate UDCA.

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Ocaliva has been shown to improve a certain blood test that measures liver problems but also has adverse liver-related reactions that may be inconsistent with the patient’s extent of disease.

Adverse Symptoms of Ocaliva

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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
Steatorrhea or Bloody stools

Reference
https://www.fda.gov/Drugs/DrugSafety/ucm576656.htm.