Promacta Lawsuit

In August 2016, Canadian drug regulators warned that Promacta (sold as Revolade in Canada) can cause severe hepatotoxicity and life-threatening liver injuries. Individuals who experienced these complications while undergoing treatment with this drug may be eligible to receive compensation via a Promacta lawsuit.

Promacta Legal Reviews

The nationwide law firm of Bernstein Liebhard LLP is now investigating legal claims involving Promacta and hepatotoxicity/severe liver injuries. If you or a loved one experienced similar harm while using this drug, please call (888) 994-5118 to discuss filing a Promacta lawsuit with a member of our legal team.

Promacta: What’s the Problem?

Promacta (eltrombopag) is approved to treat disorders that can lead to thrombocytopenia (abnormally low platelet counts). It works by stimulating the bone marrow to produce more platelets. Promacta was initially approved by the U.S. Food & Drug Administration in 2008 to treat thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulin therapy, or splenectomy. Its approved indications have since been expanded to include the treatment of patients with aplastic anemia for which immunosuppression has not been successful, as well the treatment of thrombocytopenia in pediatric patients 1 year and older with idiopathic thrombocytopenia who have not responded sufficiently to corticosteroids, immunoglobulins, or splenectomy.

In August 2016, Health Canada announced modifications to the Revolade (sold as Promacta in the U.S.) label after a review suggested that the drug could cause severe hepatotoxicity and life-threatening liver injuries. A review of data from clinical trials and post-marketing reports revealed that 5 patients experienced severe drug-induced liver injury while undergoing treatment with eltrombopag. Furthermore, 1% of patients with hepatitis C who were given eltrombopag developed liver damage. Hepatotoxicity typically occurred within 3 months and went away after discontinuing the medication.

Hepatotoxicity or drug-induced liver damage can lead to permanent liver disease and potentially-fatal liver failure. Symptoms include:

  • Jaundice
  • Severe fatigue
  • Fever
  • Abdominal pain
  • Nausea and vomiting
  • Bleeding that does not stop within few minutes
  • Unusual swelling in hands and feet

To avoid these dangerous complications, Health Canada is advising doctors to test liver function prior to prescribing Promacta. Testing should continue every two weeks while dosage is adjusted, and every month once an appropriate dose is established. Treatment with Promacta should be stopped in patients who develop elevated liver enzyme levels, especially those with pre-existing liver disease.

Learn More about Filing a Promacta Lawsuit

Individuals who suffered liver damage that could be related to Promacta may be entitled to compensation for:

  • Medical bills
  • Lost wages
  • Disability
  • Emotional distress
  • Pain and suffering
  • Wrongful death

To learn more about filing a Promacta lawsuit, please contact Bernstein Liebhard LLP at (888) 994-5118.

  1. FDA (2015) “Promacta: Highlights of Prescribing Information”
  2. Health Canada (2016) “REVOLADE (eltrombopag) – Risk of Severe Hepatotoxicity”
Last Modified: September 1, 2016

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