Promacta Study Halted Over Safety Concerns

The U.S. Food and Drug Administration (FDA) and drug maker GlaxoSmithKline (GSK) have notified healthcare professionals of a new safety finding in patients with low blood platelets due to chronic liver disease treated with <"http://www.yourlawyer.com/practice_areas/defective_drugs">Promacta (eltrombopag). A trial involving these patients was recently halted over safety issues, the agency said.

Promacta is approved in the United States for treatment of chronic immune idiopathic thrombocytopenic purpura (ITP), explained Reuters. This is a condition in which patients experience significantly lower blood-platelet counts for no known cause, a condition that places patients at risk for bruises or serious bleeding, added Reuters. Promacta was developed in partnership with Ligand Pharmaceuticals Inc., said Reuters.

The FDA said the halted trial, called ELEVATE, was conducted in patients taking Promacta, and whose low platelets were due to liver damage. In a notice on its Web site, the FDA confirm the study was stopped following an increased frequency of blood clots in patients taking Promacta, versus those taking a placebo, said Reuters.

The study was a randomized, double blind, placebo-controlled, multi-national study, and was terminated following the identification of blood clot safety issues, said Reuters. According to the FDA, an imbalance of thrombosis of the portal venous system in the patients treated with Promacta versus a matching placebo was seen.

The study revealed that six patients—or four percent—in the Promacta group experienced a thrombotic event of the portal venous system. This system, explained Reuters, is a critical blood vessel system connected to the liver. Five of the six patients treated with Promacta experienced the portal venous thrombosis at platelet counts above 200,000/μL. One patient—one percent—receiving a placebo experienced a blood clot to the Portal Venous System.

GSK communicated the safety finding to clinical trial investigators and regulatory agencies and is working with regulatory agencies to include this safety information in the label, said the FDA.

Health Care Professionals are reminded that 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. Also, treatment with Promacta should be aimed at increasing the platelet count to a level that reduces the risk of bleeding; Promacta should not be used in an attempt to normalize the platelet count, said the FDA.

Caution should always be used when administering Promacta to patients with known risk factors for thromboembolism and when administering Promacta to patients with hepatic disease. Use a lower starting dose (25mg once daily) of Promacta in patients with moderate to severe hepatic disease and monitor closely, said the FDA.

Reuters pointed out that platelets are one of the blood’s three main elements and are critical to the blood-clotting process.

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