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Cardiac Safety Alert for Users of Cancer Drug

An important notice about Gleevec, a drug used to treat chronic myeloid leukemia

The FDA has issued a safety alert about potential cardiotoxicity of imatinib mesylate (Gleevec), a drug used to treat chronic myeloid leukemia and gastrointestinal stromal tumors. In a new warning added to the drug label, the manufacturer notes that Gleevec users with heart disease or at risk for heart failure (HF) should be monitored carefully and that users who develop signs or symptoms suggesting cardiac failure should be evaluated and treated.

Although edema, dyspnea, and fluid retention are known side effects of Gleevec, the potential for cardiotoxicity had not been documented previously. A recent study described 10 patients who developed severe HF and left-ventricular dysfunction an average of 7.2 months after initiating therapy (Nat Med 2006; 12:908). All had normal baseline systolic function, and most had pretreatment risk factors such as diabetes, hypertension, or coronary artery disease. Biopsy results from these patients were consistent with toxic myopathy. In response, the manufacturer evaluated existing data from clinical trials and spontaneous reporting, and confirmed that although cardiac events associated with Gleevec use were uncommon, there is some evidence of risk for severe HF and LV dysfunction in certain users.

Comment: New evidence suggests that Gleevec may cause severe, symptomatic LV systolic dysfunction in some patients. However, existing data cannot pinpoint the magnitude of the risk or the specific patient factors that mediate it. Practitioners should be aware of the potential HF risk from Gleevec and should assess patients for signs and symptoms of HF before and during Gleevec therapy, especially patients already at risk for HF because of coexisting conditions. Routine baseline and re-evaluation echocardiography — as recommended for treatment with other cardiotoxic chemotherapy, such as the anthracyclines — also might be reasonable, although without better information about the HF risk from Gleevec, the appropriateness of this approach is not proven.

— Frederick A. Masoudi, MD, MSPH

Published in Journal Watch Cardiology November 1, 2006