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FDA Adds Boxed Warning to Ocaliva Following Dosing Errors


The U.S. Food and Drug Administration (FDA) has ordered a boxed warning and dosing table be added to the liver disease drug Ocaliva (obeticholic acid) following reports that the medication is being incorrectly dosed daily instead of weekly to patients.

About the Ocaliva Black Box Warning

Medscape reports that Ocaliva is prescribed to patients with moderate to severe primary billary cholangitis (PBC) and that the incorrect dosing results in an significantly increased risk of serious liver injury.

In a safety communication, the FDA addressed the issue saying that the dosing errors have resulted in cases of liver decompensation, liver failure, and death. In order to correct the issue, the FDA is clarifying current recommendations for screening, dosing, monitoring, and managing PBC in patients with moderate to severe liver disease taking Ocaliva.

In addition to the boxed warning and dosing table, the FDA said that it will also require Ocaliva carry a medication guide for patients that informs them about the past dosing issues and the risk of such errors.

Additional Guidelines Issued to Healthcare Professionals and Patients

Beyond packaging and label changes, the FDA advises clinicians to take the following actions when treating a patient with Ocaliva:

  • Routinely monitor patients for biochemical response, tolerability, and PBC progression.
  • Closely monitor patients who are at an increased risk of liver decompensation.
  • Make sure both patients and caregivers are educated on the symptoms of worsening liver function.
  • Temporarily stop treatment with Ocaliva if the patient displays evidence of worsening liver function.
  • Consider stopping treatment in patients who have experienced clinically significant liver-related adverse reactions.

Contact an Experienced Drug Recall Attorney

Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of recalled medications or pharmaceuticals, contact Thomas J. Henry Injury Attorneys immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

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