Novartis To Add Precaution to Gleevec

Lee Coleman

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Add congestive heart failure to the list of precautions for Gleevic (imitinib mesylate). Novartis Oncology said it would send letters to U.S. Physicians advising them of the possible link. Gleevec is used for chronic myeloid leukemia and gastrointestinal stromal tumors (GIST). The FDA approved Gleevec in May of 2001. Novartis said it already included data about heart failure but would add more literature about congestive heart failure.

"The spokesperson said the Gleevec label will now include language that cautions physicians to carefully monitor patients with cardiac disease or patients who may be at risk for developing cardiac disease. "