Ocaliva Dosing Problems May Increase Liver Injury Risks, FDA Warns

At least 19 deaths may be linked to problems with Ocaliva, a liver disease drug that is being incorrectly dosed in some patients, placing them at serious risk, according to warnings issued by federal drug regulators this week. 

In a safety announcement issued on September 21, the FDA warns that incorrect dosing of Ocaliva among individuals with moderate to severe decreases in liver function may result in a risk of serious liver injury or death. Ocaliva dosing problems can also cause liver injury among individuals who only suffer mild liver disease, the agency warns.

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 only been on the market for less than a year and a half, 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 Ocavila daily.

The problem with Ocavila 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 Ocavila 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 recommends that health care professionals determine the patient’s baseline liver function before starting them on an Ocavila regimen, and then start qualified patients with moderate to severe liver impairment on a dosing schedule of no more than 5 mg once weekly. If necessary, it can be increased to the maximum recommended 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,” the FDA advises. “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).”

The agency instructs doctors to discontinue Ocaliva treatment if liver injury is suspected, and then weigh the benefits against the risks before putting those patients back on the medication.

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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