FDA warns MS patients not to use Campath.
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
|Printer friendly Cite/link Email Feedback|
|Title Annotation:||United States. Food and Drug Administration|
|Date:||Dec 15, 2005|
|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.|