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May 13, 2010 – The American Food and Drug Administration (FDA) posted yesterday the following Safety Information Text (italic):
GlaxoSmithKline and FDA notified healthcare professionals of a new safety finding in patients with thrombocytopenia due to chronic liver disease treated with Eltrombopag [Promacta], a thrombopoietin receptor agonist approved for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura. The ELEVATE study, a randomized, double-blind, placebo-controlled, multinational study was terminated following the identification of an imbalance of thrombosis of the portal venous system in the patients treated with Eltrombopag [Promacta] versus matching placebo. Six patients (4%) in the Eltrombopag [Promacta] group and one (1%) in the placebo group experienced a thrombotic event of the portal venous system. Five of the six patients treated with Eltrombopag [Promacta] experienced the portal venous thrombosis at platelet counts above 200,000/μL. GSK has communicated this safety finding to clinical trial investigators and regulatory agencies. GSK is working with regulatory agencies to include this safety information in the label.
Action required by Health Care Professionals:
- Health Care Professionals are reminded that Eltrombopag [Promacta] is indicated for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and is not indicated for the treatment of thrombocytopenia in patients with chronic liver disease.
- Treatment with Eltrombopag [Promacta should be aimed at increasing the platelet count to a level that reduces the risk of bleeding; Eltrombopag [Promacta should not be used in an attempt to normalize the platelet count.
- Use caution when administering Eltrombopag [Promacta] to patients with known risk factors for thromboembolism.
- Exercise caution when administering Eltrombopag [Promacta] to patients with hepatic disease. Use a lower starting dose (25mg once daily) of Eltrombopag [Promacta] in patients with moderate to severe hepatic disease and monitor closely.
You can access the Dear Healthcare Professional Letter here.
Please not the Eltrombopag has just (March 2010) been granted the Market Authorization for the European Union (EU) by the EMEA. It will be marketed in the EU under the name Revolade. See the graph above, taken from ThassoBase, for the chemical structure of Eltrombopag.