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Novartis Cancer Drug May Harm Heart, Study Says

July 24, 2006|From the Associated Press

WASHINGTON — A successful cancer-fighting drug may also damage the heart, although a researcher says leukemia patients who need Gleevec should not abandon it.

While effectively treating cancer, Gleevec can lead to heart failure in some patients, said Dr. Thomas Force, who teaches medicine at Jefferson Medical College of Thomas Jefferson University in Philadelphia.

His study, published Sunday in the online edition of the journal Nature Medicine, was prompted by reports that 10 patients taking Gleevec for chronic myelogenous leukemia developed severe congestive heart failure.

Gleevec, sold under the name Glivec in some countries, had worldwide sales of $1.2 billion in the first six months of this year, according to the manufacturer, Novartis Pharmaceuticals Corp.

"Gleevec is a wonderful drug and patients with these diseases need to be on it. It's a lifesaving drug for sure," Force said in a telephone interview.

"This is not a Vioxx situation," Force added, referring to Merck & Co.'s painkiller that was pulled from the market because of heart side effects.

Force said he was trying to call attention to the fact that Gleevec and other similar drugs coming along could have significant effects on the heart and that doctors need to be aware of this and watch for symptoms. These patients can be helped with heart treatment, he said.

Novartis cited the limited data and said further research was needed.

The company said in a written statement that the prescribing information with the drug included data on heart problems. In addition, the drug maker said clinical trials and post-marketing safety data have shown that heart failures among people taking the drug were "extremely rare."

Novartis said Force's work did not change "the positive benefit/risk ratio of Glivec for thousands of patients being treated for cancer and other life-threatening diseases."

Force said the 10 patients with heart failure were taking Gleevec at the University of Texas' M.D. Anderson Cancer Center in Houston and had no heart problems before going on the drug.

He said doctors took baseline measures of the patients' left ventricular heart function and determined that heart failure developed in these patients two months to 14 months after they began Gleevec.

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