Novartis to Add Congestive Heart Failure to Gleevec Precautions

FLORHAM PARK, N.J., Oct. 3 -- Novartis Oncology said today it would send letters to U.S. physicians this week advising them of a possible link between Gleevec (imitinib mesylate) and congestive heart failure.

Gleevec is approved for chronic myeloid leukemia and gastrointestinal stromal tumors (GIST). The oral tyrosine kinase inhibitor was approved by the FDA in May 2001.

A company spokesperson said Novartis will also add additional information about congestive heart failure to the precautions section of the Gleevec label. He said the FDA has approved both the label revision and the letter to doctors.

Novartis announced a similar agreement yesterday, with Health Canada.

The spokesperson said that the company has not changed its estimate of the risk of congestive heart failure, which he said was estimated at 0.1% to 1%, calculated on the basis of on post-marketing data from some 100,000 Gleevec patients worldwide.

Animal studies published in Nature Medicine in August suggested that an unintended side-effect of Gleevec's BCR-ABL inhibition may be development of cardiac dysfunction.

The spokesperson said the Gleevec label will now include language that cautions physicians to carefully monitor patients with cardiac disease or patients who may be at risk for developing cardiac disease.

The spokesperson noted that the company thinks the benefit of Gleevec, with 90% of CML patients who have been taking the drug alive at five years, outweighs the slight cardiovascular risk.