Ocaliva Dosing Problems Lead To FDA Black Box Warning

The FDA is requiring a new “black box” warning about the risk of medication errors with Ocaliva, a liver disease drug that has been linked to at least 19 deaths and a number of reports involving serious liver injury.

In a drug safety communication issued on February 1, the agency announced that the strongest label warning will be added to the drug, clarifying current recommendations for screening, dosing, monitoring and managing patients using Ocaliva. The new requirements also call for a medication guide to inform patients about the dosing problems.

Ocaliva (obeticholic acid) is an Intercept Pharmaceuticals drug first approved in May 2016. It is used to treat primary billary cholangitis (PBC), a rare and chronic form of liver disease. PBC can cause inflammation and destruction of bile ducts in the liver, resulting the bile to build up and damage the liver over time.

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Although it has been on the market for less than two years, Ocaliva has been linked to 19 deaths and 11 cases of serious liver injury. In eight of the deaths the FDA investigated, seven involved worsening PBC. Seven of the cases also involved patients suffering moderate to severe decreased liver function after taking 5 mg of Ocaliva daily.

The problem with Ocaliva stems from recommendations that individuals with moderate to severe decreased liver function should take no more than 10 mg of the drug twice weekly. If patients with that level of impairment are taking 5 mg of Ocaliva daily, that puts them at 35 mg per week. While taking 10 mg twice weekly, as recommended, means that patients should only be taking 20 mg per week.

The FDA first announced the Ocaliva liver concerns in a September 2017 drug safety communication.

The agency is calling for health care professionals to follow the dosing regimen on the drug label, and to routinely monitor patients for biochemical response, tolerability, and primary billary cholangitis progression. They should re-evaluate the Child-Pugh classification used to determine dosing if they believe dosage adjustment is necessary. Patients at risk of liver decompensation, and those with signs of worsening liver function, should be closely monitored, according to the recommendations.

The FDA advises patients to contact their health care professional if they are taking Ocaliva if they develop:

  • New or worsening severe skin itching
  • New or worsening fatigue
  • Abdominal pain
  • Abdominal swelling
  • Diarrhea
  • Weight loss
  • Decreased appetite
  • Nausea and vomiting
  • Behavioral changes, confusion, or anxiety
  • Yellow eyes or skin
  • Bloody stools

The FDA urges health care professionals and patients to report any Ocaliva side effects to the FDA’s MedWatch adverse event reporting program.


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