FDA: Alemtuzumab (marketed as Campath) Information

FDA ALERT [11/2005]

ROCKVILLE, Md., Nov. 30, 2005-Three patients in a clinical study of the drug Campath for the treatment of Multiple Sclerosis (MS) developed severe idiopathic thrombocytopenic purpura (ITP). One of the patients died.

ITP happens when the body attacks and kills its own blood platelets. Platelets are a type of blood cell that controls bleeding. Bruising and bleeding may be warning signs of ITP.

Campath is not approved to treat MS. Campath is only approved for treating a form of blood cancer called B-cell chronic lymphocytic leukemia (B-CLL). The label for Campath has a warning about serious and rare blood problems that may happen with the use of this medicine.

Talk to your healthcare professional if you have concerns about taking Campath.

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

• Patient Information Sheet - attached
• Healthcare Professional Information
• Healthcare Professional Sheet - attached
• Prescribing Information - attached

Downloads
alemtuzumabPIS.pdf
Healthcare2.pdf
Prescribing.pdf

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