FDA issues portal venous thromboses warning with Promacta
GlaxoSmithKline and the FDA notified healthcare professionals of a new safety finding in patients with thrombocytopenia due to chronic liver disease treated with Promacta (eltrombopag tablets). 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 Promacta versus matching placebo. Six patients (4%) in the 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 Promacta experienced the portal venous thrombosis at platelet counts above 200,000/μL. GlaxoSmithKline is working with regulatory agencies to include this safety information in the label. The FDA issued the following statements directed to healthcare professionals.
Promacta is indicated for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP). It is not indicated for the treatment of thrombocytopenia in patients with chronic liver disease.
Treatment with Promacta should be aimed at increasing the platelet count to a level that reduces the risk of bleeding. It should not be used to normalize the platelet count.Use caution when administering Promacta to patients with known risk factors for thromboembolism or with hepatic disease. Use a lower starting dose (25mg once daily) of Promacta in patients with moderate to severe hepatic disease and monitor closely.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm211796.htm.