FDA, Novartis Issue Gleevec Safety Alert
Patients with cardiac disease require careful monitoring
FRIDAY, Oct. 20 (HealthDay News) -- The U.S. Food and Drug Administration and Novartis Pharmaceuticals have issued a safety alert for possible severe congestive heart failure and left ventricular dysfunction in patients taking Gleevec (imatinib mesylate).
In a letter addressed to health care professionals, John Hohneker, M.D., vice president at Novartis, reported data from a randomized phase 3 study that found occasional severe congestive heart failure and left ventricular dysfunction in treated patients, mostly in the elderly and those with previous cardiac disease.
The study data included 1,106 patients with Philadelphia-negative chronic myeloid leukemia. Severe cardiac failure and left ventricular dysfunction was noted in 0.7 percent of those on Gleevec compared to 0.9 percent for those taking interferon alpha plus cytarabine.
"While cardiac events remain uncommon, severe congestive heart failure and left ventricular dysfunction have occasionally been reported. As such we believe any patients with known cardiac disease or risk factors for cardiac failure should be monitored carefully, and any patient with symptoms consistent with cardiac failure should be evaluated and treated," Hohneker wrote.
Adverse events related to the product can be reported to the FDA at www.fda.gov/MedWatch/report.htm, by phone (1-800-FDA-1088), or via a downloaded form that can be mailed to the federal agency.