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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.

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Title Annotation:United States. Food and Drug Administration
Publication:Transplant News
Geographic Code:4EUGE
Date:Dec 15, 2005
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