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Risk of Severe Liver Damage with Revolade, Health Canada Warns

Aug 26, 2016

Revolade (eltrombopag) can cause severe, potentially fatal liver injury, Health Canada warns. In a safety alert issued on Aug. 25, the regulators said that some patients experienced cases of severe drug-induced liver injury while taking the drug during clinical trials and post-marketing. Revolade is manufactured by Novartis; it is used to increase platelet counts in patients with certain health conditions.

Platelets are components of the blood that help with coagulation. Revolade is used to increase platelet counts in adult patients with chronic immune thrombocytopenia purpura, patients who have had their spleen removed and are unable to take first-line treatments such as corticosteroids and immunoglobulins, thrombocytopenic (low platelet count) patients with chronic hepatitis C virus infection and patients with severe aplastic anemia who do not respond well to immunosuppressants.

The safety alert warns “REVOLADE administration can cause severe hepatotoxicity and potentially fatal liver injury. Cases of severe drug-induced liver injury with REVOLADE have been reported in patients during clinical trials and post-marketing.” Health Canada advises healthcare professionals to measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin before starting treatment, every two weeks during dose adjustment and then monthly afterwards.

In its review of all clinical trial and post-marketing data, Health Canada said it identified five cases of severe drug-induced injury that fulfilled Hy’s law criteria, a general rule of thumb used to determine whether a drug has a high risk of causing fatal drug-induced liver injury if given to a large population. A drug must first satisfy certain criteria causing liver damage in a smaller population first.

Among the five cases, two were patients with chronic ITP and three were patients taking the drug for unapproved uses. The elevated laboratory values, which indicate liver damage, usually occurred within three weeks of starting Revolade. Once treatment was stopped, the liver injury resolved in these patients. In clinical trials among patients with chronic hepatitis C infection, 11 patients (1 percent) developed drug-induced liver injury.

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