Cardiac Safety Alert for Users of Cancer Drug

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 M…