Eltrombopag (Promacta®) - Portal Venous System Thromboses in Patients with Chronic Liver Disease
May 14, 2010
FDA and GlaxoSmithKline are notifying healthcare professionals of an increased incidence of portal venous system thromboses seen in patients taking eltrombopag for thrombocytopenia due to chronic liver disease during a clinical trial (ELEVATE). The ELEVATE trial was stopped early after finding an increased incidence of portal venous system thrombosis in patients treated for 14 days with eltrombopag 75 mg orally daily (6 patients; 4%) compared with placebo (1 patient, 1%). Platelet counts in 5 of 6 patients in the eltrombopag group who experienced portal venous system thromboses exceeded 200,000 per microliter. GlaxoSmithKline is evaluating this clinical trial data and will continue to review new safety data including post-marketing adverse event reports.
Eltrombopag is a thrombopoietin receptor agonist labeled to treat thrombocytopenia in adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have not adequately responded to other treatments. Eltrombopag is not approved for the treatment of thrombocytopenia in patients with chronic liver disease. Eltrombopag should be used to increase the platelet count to a level that reduces bleeding risk and should not be used to normalize the platelet count.
Healthcare providers should use caution when prescribing eltrombopag in patients with increased risk for thrombotic events. Use caution when using eltrombopag in patients with liver disease. In patients with moderate to severe hepatic impairment, use a lower starting dose of 25 mg orally once daily.
Additional Information is available at the following links:
- MedWatch Alert
- Dear Healthcare Professional Letter
May 14, 2010; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.