NOVARTIS INCLUDES HEART FAILURE WARNING ON GLEEVEC LABELING

A study showing that patients taking Gleevec could be at increased risk for certain cardiovascular problems has resulted in Novartis changing the labeling for the blockbuster cancer drug.

The "Precautions" section of Gleevec's prescribing information will now contain information on the potential for severe congestive heart failure and left ventricular dysfunction in patients taking the drug. The label warns that any patient with risk factors for cardiac failure should be closely monitored while taking the drug. Novartis and the FDA alerted healthcare professionals to the label changes Oct. 19.

The changes came after a study published in the July 23 issue of Nature Medicine showed that Gleevec could have cardiovascular side effects. Researchers began the study after noticing that 10 patients taking Gleevec developed severe congestive heart failure and left ventricular dysfunction after having normal functioning in those areas before taking the drug. The 10 patients had chronic myelogenous leukemia.

Gleevec is a tyrosine kinase inhibitor, which hinders cell communication and growth. Researchers hypothesized that the enzymes that Gleevec inhibits may be essential for the health of heart cells. Any similar tyrosine kinase inhibitor could have the same risk of cardiac problems, Novartis said.

The letter Novartis sent to healthcare professionals can be viewed at www.fda.gov/medwatch/safety/2006/Gleevec_DHCP_10-19-2006.htm (http://www.fda.gov/medwatch/safety/2006/Gleevec_DHCP_10-19-2006.htm).