Case Evaluation

Gleevec: Heart Precaution Added to Gleevec Label

Heart Precaution Added to Gleevec Label

October 20, 2006

The U.S. Food and Drug Administration announced yesterday a labeling change to the breakthrough cancer drug Gleevec. The drug's label now mentions the risk of severe congestive heart failure. On Thursday, the maker of Gleevec - Novartis - issued a letter, informing healthcare professionals of the increased heart risks associated with the drug. Gleevec has been hailed as a wonder drug for its effectiveness in treating chronic myelogenous leukemia (CML) and gastrointestinal stromal tumors. Four months ago, however, a study published in the journal Nature Medicine linked the drug with severe congestive heart failure.

According to experts, patients with a history of diabetes, high blood pressure, and coronary artery disease face the greatest risk of heart failure while taking Gleevec. Doctors have been urged to monitor patients with these and other risk factors carefully. "The only thing this changes is the discussion that you have with the patient when you're talking about starting the medication, and it might also change how you monitor the patient," said Dr. Jonathan Goldberg, a hematology oncologist in New York. Similar drugs known as tyrosine kinase inhibitors may also damage the heart, said Dr. Len Lichtenfield of the American Cancer Society. "The reality is that they, too, because of the particular way Gleevec causes heart failure problems, are suspect," he said.

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