October 19, 2006: Gleevec Prescribing Information Revised
The U.S Food and Drug Administration (FDA) and Novartis Pharmaceuticals Corporation notified healthcare professionals about revisions to the prescribing information for cancer drug Gleevec, which now describes the occasional occurrence of severe congestive heart failure and left ventricular dysfunction. Most patients reporting cardiac events had other risk factors, including advanced age and previous medical history of cardiac disease. The prescribing information now advises that Gleevec patients with cardiac disease (or risk factors for cardiac failure) be monitored carefully. More information from the FDA: "Dear Healthcare Professional" Letter and Revised Gleevec Label [PDF].
August 17, 2006: Recent Studies Suggest Gleevec Causes Heart Failure in Cancer Patients
Recent studies suggest that Gleevec can cause heart problems for patients taking the drug to treat Chronic Myeloid Leukemia (CML). In its August 2006 publication, Nature Medicine reported a study of ten CML patients who were treated with Gleevec and developed congestive heart failure after one to fourteen months. On the other hand, studies have also shown that Gleevec keeps between 80% and 90% of CML patients cancer free for at least five years. Because the overall survival rate of most CML patients treated with Gleevec is extremely high, and because the cancer relapse rate (as well as the number of reported heart failures) is low, many say that the benefits of Gleevec outweigh its risks. Click here to see the abstract in PubMed, a service of the U.S. National Library of Medicine.
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