Printer Friendly
The Free Library
23,416,918 articles and books


FDA warns MS patients not to use Campath.

The FDA 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 B-CLL).

The FDA Alert said three MS patients in a clinical trial of Campath developed severe idiopathic thrombocytopenic purpura (ITP). One of the patients died.

"ITT 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
COPYRIGHT 2005 Transplant Communications, Inc.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005 Gale, Cengage Learning. All rights reserved.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Title Annotation:United States. Food and Drug Administration
Publication:Transplant News
Geographic Code:4EUGE
Date:Dec 15, 2005
Words:169
Previous Article:Vertex to start Phase II trial for investigational Oral HCV protease inhibitor, FDA grants Fast Track designation.
Next Article:First face transplant, Internet solicitation for donors, fabricated stem cell data major news events in 2005.
Topics:



Related Articles
ILEX Oncology and Millennium submit biologics license application for CAMPATH.
Genzyme completes acquisition of Ilex Oncology, enters gene therapy collaboration with AGTC.
FDA panel recommends Sanofi-Aventis antibiotic Ketek have label warning possible liver toxicity.
Roche to add warning label to Tamiflu.
FDA restricts use of Sanofi-Aventis' Ketek; orders strict new labeling with a 'boxed warning'.
FDA strengthens safety info for ESA's manufactured by Amgen, Ortho Biotech.
FDA strengthens boxed warnings for high profile drugs-Avandia, and ESAs Aranesp, Epogen, and Procrit.

Terms of use | Copyright © 2014 Farlex, Inc. | Feedback | For webmasters