FDA Warns of Liver Injury from Improper Ocaliva Dosing

Thursday, February 15, 2018

The FDA last week issued a new warning for the liver disease medicine Ocaliva, requiring the manufacturer to add precautions to the drug’s label that improper dosage may cause increased liver injury.

The warning comes after the agency flagged Ocaliva last year in a review of their Adverse Event Reporting System which uncovered an increasing number of patients developing liver injury after taking the drug.


Ocaliva Approved With Limited Data

Ocaliva, from New York-based Intercept Pharmaceuticals, is a drug used to treat a rare and chronic liver disease known as Primary biliary cholangitis (PBC). It is also known as obeticholic acid.

PBC slowly damages the bile ducts in the liver that move bile into the small intestines to digest food. The disease can develop slowly leading to delayed diagnosis. If left untreated, it can cause damaged liver cells, cirrhosis and eventually liver failure.

Ocaliva is taken orally and works by binding to the farnesoid X receptor in liver cells. It promotes flow of bile from the liver and restricts it from making too much bile, thereby protecting it from dangerous acid levels.

Ocaliva received accelerated approval by the FDA in May of 2016 after clinical trials showed good response in patients with PBC. It is often prescribed along with a similar drug called ursodeoxycholic acid (UDCA).

However, the speed of approval left questions as to the drug’s long-term affects and whether it can continue to control the symptoms of PBC. Therefore, the FDA required the manufacturer to continue studying its safety. Those trials are still ongoing and expected to be completed by 2023.


FDA Warns of Increased Adverse Events

Each quarter, the FDA publishes a list of drugs with the potential for serious and undisclosed side effects based on information received in its Adverse Event Reporting System.

The report is called Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS).

In its July – September 2017 Potential Signal report, the agency identified Ocaliva as a potential risk after an increased number of reports showing patients suffering liver injury. At the time, the FDA said it was evaluating the need for regulatory action.


FDA Adds Black Box Warning for Liver Damage

On February 1, the FDA added a new warning to the label of Ocaliva, indicating that the current label didn’t adequately explain dosing requirements. As a result, health care professionals have been improperly dosing the drug on a daily basis rather than weekly, which can cause increased risks of liver damage.

This type of Boxed Warning is the most prominent type of warning used by the FDA, based on the risks.

Under the new dosage guidelines, doctors should classify patients and their required dosages based on the Child-Pugh scale. If not, they may receive higher-than-necessary doses which can lead to liver decompensation, liver failure or death.

Doctors should monitor patients taking Ocaliva for any complications from the drug, for signs of PBC worsening, for signs of liver damage, and by re-evaluation to determine if dosage needs to be adjusted.

The FDA also cautioned patients taking Ocaliva to monitor for any signs of liver problems, to report any symptoms to their doctor, and to make sure their doctor is performing periodic tests for liver health.

Some of the symptoms of liver damage include:

  • Jaundice
  • Severe or persistent nausea, vomiting or diarrhea
  • Coughing or vomiting blood
  • Black or bloody stools
  • Abdominal pain or swelling
  • Persistent tiredness or weakness
  • Fever or chills
  • Confusion
  • Slurred speech
  • Lightheadedness

If patients notice the persistence of any of the above problems, they should contact their doctor immediately.

DrugNews will continue to monitor the studies and safety profile for Ocaliva and provide any updates as they become available.



FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease. FDA. (February 1, 2018). Retrieved from https://www.fda.gov/drugs/drugsafety/ucm594941.htm

FDA. Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS): July - September 2017. (January 12, 2018). Retrieved from https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm592379.htm


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