FDA warns MS patients not to use Campath.The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has issued a warning against the use of Campath in patients with multiple sclerosis. Campath is co-marketed by the Genzyme Corporation, Cambridge, MA, and Berlex, Inc., a unit of German-based Schering AG, and is currently FDA-approved to treat a type of leukemia, B-cell chronic lymphocytic leukemia chronic lymphocytic leukemia n. Abbr. CLL Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms. B-CLL). The FDA Alert said three MS patients in a clinical trial of Campath developed severe idiopathic thrombocytopenic purpura Idiopathic Thrombocytopenic Purpura Definition Idiopathic thrombocytopenic purpura, or ITP, is a bleeding disorder caused by an abnormally low level of platelets in the patient's blood. (ITP ITP - Intent to Package ). One of the patients died. "ITT ITT Initial Teacher Training (UK) ITT I Think That ITT Invitation To Tender ITT Individual Time Trial (professional cycling) ITT Intention-To-Treat ITT In This Thread (forums) happens when the body attacks and kills its own blood platelets," FDA said. "Platelets are a type of blood cell that controls bleeding. Bruising and bleeding may be warning signs of ITP." Dan Quinn, a Genzyme spokesman, told the Wall Street Journal the company is still discussing the clinical results of Campath in treating MS patients and is working on a risk management program for additional studies. Genzyme and Schering hope to begin larger, Phase III studies of Campath in MS patients in the second half of next year. Contact: Web site: www.genzyme.com |
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