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Promacta Liver Damage

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Regulators in Canada have warned that Promacta may cause serious liver damage. New information regarding this potential complication has been added to the drug’s label in Canada, where Promacta is sold as Revolade.

Legal Assistance for Those Harmed by Promacta

The attorneys at Bernstein Liebhard LLP are available to provide legal assistance to individuals who may have suffered liver damage due to Promacta, including hepatotoxicity and liver failure. To learn if you might be eligible to file a Promacta lawsuit, please contact our Firm by calling (888) 994-5118.

Promacta Liver Injury Warning

Promacta (eltrombopag) is a thrombopoietin receptor agonist that is used to increase blood platelet counts in people with thrombocytopenia (abnormally low platelet counts). It was developed by GlaxoSmithKline and approved by the U.S. Food & Drug Administration (FDA) in 2008. The medication was acquired by Novartis in 2015.

Promacta is sold as Revolade in Canada and the European Union. In the U.S., Promacta was granted orphan drug status, which allows a drug temporary market exclusivity to encourage companies to develop treatments for rare conditions. Promacta’s current indications include:

• Treatment of thrombocytopenia in adult and pediatric patients 1 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
• Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.
• Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

In the U.S., Promacta’s prescribing information bears a black box warning regarding the potential for serious liver problems. The warning notes the risk of liver problems may be increased in people with chronic hepatitis C virus who take Promacta with interferon and ribavirin treatment.

In August 2016, Health Canada announced that the Revolade label would be modified to include information regarding hepatotoxicity and potentially fatal liver injury, which have been reported in patients during clinical trials and post-marketing. These reports included 5 patients who had experienced severe drug-induced liver injury, as well as 11 hepatitis patients who suffered liver damage following treatment with Promacta. Hepatotoxicity typically occurred within 3 months and went away after discontinuing the medication, Health Canada said.

Doctors in Canada have been advised to test liver function prior to prescribing Promacta. Liver function should also be tested 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.

What is Hepatotoxicity?

The liver is the largest organ in the body, and one of its most important functions is to filter toxins from the blood. Hepatotoxicity refers to chemical-induced liver damage that causes the liver to under function or function irregularly.  Symptoms include:

• Jaundice:
• Severe fatigue
• Fever
• Abdominal pain,severe nausea and vomiting
• Bleeding that does not stop after a few minutes
• unusual swelling in the feet and legs
• Weight gain of greater than 3 to 5 pounds in 1 week

Treatment of drug-induced liver injury generally involves stopping the medication responsible. Failure to do so may result in liver failure, need for a liver transplant, or death.

Learn More about Filing a Promacta Lawsuit for Liver Damage

Bernstein Liebhard LLP is now evaluating Promacta liver damage claims. To obtain a free, no-obligation review of your case, please call (888) 994-5118.