4 results

• FDA Warns of Ocaliva Liver Injury Risks Linked to Autoimmune Disorder Drug

  December 13, 2024

  Martha Garcia

  Federal regulators warns that the autoimmune treatment Ocaliva has been linked to liver damage and failure, resulting in patient deaths and the need for transplants.

• Ocaliva Side Effects Linked to Severe Liver Injuries in Some Cirrhosis Patients: FDA Warning

  May 27, 2021

  Irvin Jackson

  The FDA has added a new warning to the liver drug Ocaliva, barring its use in patients with primary biliary cholangitis and advanced cirrhosis of the liver, due to the risk of liver failure.

• Ocaliva Dosing Problems Lead To FDA Black Box Warning

  February 2, 2018

  Irvin Jackson

  The FDA is adding a new black box label warning to labels of Ocaliva, following reports of at least 19 deaths linked to incorrect dosing and severe liver injury.

• Ocaliva Dosing Problems May Increase Liver Injury Risks, FDA Warns

  September 22, 2017

  Austin Kirk

  The FDA is warning that the liver disease drug Ocaliva has been linked to cases of severe liver injury and death when inappropriate doses have been prescribed.