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Obeticholic acid FDA Alerts

The FDA Alerts below may be specifically about obeticholic acid or relate to a group or class of drugs which include obeticholic acid.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for obeticholic acid

Ocaliva (obeticholic acid): Drug Safety Communication - Boxed Warning Added To Highlight Correct Dosing

ISSUE: FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of serious liver injury. To ensure correct dosing and reduce the risk of liver problems, FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva. FDA is adding a new Boxed Warning, FDA’s most prominent warning, to highlight this information in the prescribing information of the drug label. FDA is also requiring a Medication Guide for patients to inform them about this issue.

As a condition of approval, FDA required the manufacturer of Ocaliva, 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. FDA is adding the additional warnings to the drug label after receiving reports that Ocaliva is being given to PBC patients with moderate to severe liver impairment more often than is recommended in the prescribing information, resulting in liver decompensation, liver failure, and sometimes death. FDA will continue to monitor this medicine and will update the public if new information becomes available.

BACKGROUND: This is an update to the MedWatch safety alert for Ocaliva (obeticholic acid) - Increased Risk of Serious Liver Injury, issued 09-21-2017.

RECOMMENDATION: Health care professionals should follow the Ocaliva dosing regimen in the drug label, which is based on calculating a Child-Pugh score in PBC patients with suspected liver cirrhosis before treatment to determine their specific classification and starting dosage (see Table for the Clarified Ocaliva Dosage Regimen and more detailed instructions).  Dosing higher than recommended in the drug label can increase the risk for liver decompensation, liver failure, and sometimes death. Routinely monitor all patients for biochemical response, tolerability, and PBC progression, and re-evaluate Child-Pugh classification to determine if dosage adjustment is needed.  Close monitoring is recommended for patients at an increased risk of liver decompensation, including those with laboratory evidence of worsening liver function (e.g., total bilirubin, INR, albumin) or progression to cirrhosis.
 
Educate patients and caregivers on the symptoms of worsening liver function. Temporarily stop Ocaliva in those with laboratory or clinical evidence of worsening liver function that may indicate decompensation and monitor the patient’s liver function. If a patient’s condition returns to baseline, weigh the potential risks and benefits of restarting Ocaliva. Re-initiate, using the recommended starting dosage based on Child Pugh classification.  Consider discontinuing Ocaliva in patients who have experienced clinically significant liver-related adverse reactions.
 
Patients should be aware that your prescriber should do regular tests to check how well your liver is working while you are taking Ocaliva. If your liver problems get worse, your dose may need to be changed or stopped.  Report new or worsening severe skin itching to your health care professional. See the Drug Safety Communication for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


Ocaliva (obeticholic acid): Drug Safety Communication - Increased Risk of Serious Liver Injury

ISSUE: FDA is 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. These 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. FDA is working with the drug manufacturer, Intercept Pharmaceuticals, to address these safety concerns.

BACKGROUND: 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.

RECOMMENDATIONS:

Health care professionals

  • Determine the patient’s baseline liver function prior to starting Ocaliva.
  • Patients with moderate to severe liver impairment (Child-Pugh B and C) should be started on the approved dosing schedule of 5 mg once weekly, rather than the 5 mg daily dosing used for other PBC patients, and if needed, can be increased up to a maximum approved dose of 10 mg twice weekly.
  • Health care professionals should monitor patients frequently for disease progression, and reduce the dosing frequency to once- or twice-weekly for patients who progress to moderate or severe liver impairment.
  • In all patients treated with Ocaliva, monitor frequently for liver injury (e.g., worsened liver blood tests and adverse liver-related reactions that may be inconsistent with the patient’s extent of disease). If liver injury is suspected, discontinue Ocaliva. After the patient has stabilized, weigh the benefits against the risks when deciding whether to re-initiate treatment.
  • Educate patients on the symptoms of potential liver injury.

Patients

  • Contact your health care professional if you have questions or concerns about taking Ocaliva.
  • Report new or worsening severe skin itching to your health care professional.
  • Contact your health care professional immediately if you develop any of the following symptoms that 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

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[09/21/2017 - Drug Safety Communication - FDA]


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