August 30, 2016 — Promacta has been associated with cases of severe, life-threatening liver damage and hepatotoxicity, according to warnings issued by Health Canada.
Promacta (eltrombopag) is sold under the brand-name Revolade in Canada and the European Union. It was approved in the United States in August 2015 to increase blood platelet count in patients with a rare blood disorder.
In clinical trials and post-marketing, 5 patients experienced severe drug-induced liver injury. Furthermore, 1% of patients with hepatitis C who were given Promacta (11 patients) developed liver damage. Hepatotoxicity typically occurred within 3 months and went away after discontinuing Promacta.
Liver function should be tested before started Promacta, every 2 weeks while the dose is being adjusted, and once a month after a stable dose is established.
Health Canada has added stronger warnings about liver damage to the label on Promacta. The agency recommends discontinuing the drug in patients who develop elevated liver enzyme levels, especially those with pre-existing liver disease.
Drug-induced liver damage is also known as hepatotoxicity. It can cause permanent liver disease and deadly liver failure. The symptoms may include:
- Jaundice (yellowing of skin and eyes)
- Severe fatigue
- Fever
- Abdominal pain
- Nausea and vomiting
- Bleeding that does not stop after a few minutes
- Unusual swelling in hands and feet
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The Schmidt Firm, PLLC is currently accepting drug induced injury cases in all 50 states. If you or somebody you know has been diagnosed with hepatotoxicity, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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