FDA warns of liver damage linked to excessive dosing of liver disease Ocaliva

Patients who are prescribed an excessive dosage of chronic liver disease medication Ocaliva® may face an increased risk of serious liver injury and possibly death, the Food and Drug Administration warned.

Manufactured by Intercept Pharmaceutical, Ocaliva was approved by the FDA in May 2016 and is used to treat primary biliary cholangitis (PBC), a rare form of liver disease that causes the bile ducts to become inflamed, leading to bile build-up and liver damage.

In just over a year since Ocaliva was approved, the FDA announced that it received reports of 19 deaths and 11 cases of serious liver injuries in patients who had taken Ocaliva. Of the 11 cases of serious liver injury, three later died.

In many of the cases, the patients had moderate to severe decreased liver function and were prescribed 5mg of Ocaliva on a daily basis. The drug’s label, however, recommends a dose no greater than 10 mg twice weekly for that extent of liver damage, the FDA stated.

The FDA recommends that health care professionals carefully determine a patient’s baseline liver function before starting Ocaliva in order to ensure that the correct dosage is prescribed. Doctors should also closely monitor for disease progression and reduce dosage if needed.

Signs of liver injury and disease progression include:

  • Abdominal pain
  • Abdominal swelling
  • Bloody stools  
  • Change in behavior or confusion
  • Decreased appetite
  • Diarrhea
  • Nausea and vomiting
  • New or worsening fatigue
  • Vague symptoms such as anxiety or unease
  • Weight loss
  • Yellow eyes or skin

The FDA states that it is working with Intercept Pharmaceuticals to address safety concerns involving Ocaliva.

Motley Rice medical attorney Carmen Scott has experience litigating cases alleging severe complications caused by medications, including life-threatening liver injury and failure allegedly caused by Tylenol. If you or a loved one experienced worsening symptoms after taking Ocaliva, contact attorney Carmen Scott at 1.800.768.4026 or by email for more information