Cardiac Events with Gleevec (Feb. 2007)

Novartis is notifying healthcare professionals about new precautions for Gleevec (imatinib mesylate). Gleevec is used to treat certain patients with chronic myeloid leukemia and gastrointestinal stromal tumors.

A recent article published in Nature Medicine reported on ten patients taking Gleevec who developed severe congestive heart failure and left ventricular dysfunction. Before starting treatment, most of these patients had
pre-existing conditions such as hypertension, diabetes and
coronary artery disease. The article also reported on preclinical studies showing that mice treated with the drug developed left ventricular contractile dysfunction.

Novartis has now added a precaution to the drug labeling about severe congestive heart failure and left ventricular dysfunction. The company also says that patients with cardiac disease or risk factors for cardiac failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac failure should be evaluated and treated.

Additional Information:

FDA MedWatch Safety Alert - Gleevec (imatinib mesylate) -- October 19, 2006.
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Gleevec

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News & Politics

Tags:

• Gleevec
• Imatinib
• Mesylate
• Cardiac
• Events
• FDA
• Myeloid
• Leukemia
• Gastrointestinal
• Stromal
• Tumors
• Congestive
• Heart
• Failure