Breakthrough Cancer Drug Gleevec Gets Heart Precaution

|

Gleevec (by Novartis) may apparently cause some serious heart problems.

The small study detailed how Gleevec inadvertently targets a protein maintaining cells that contract the heart muscle and help to force blood through the body. This means that other drugs in the same class, tyrosine kinase inhibitors, may also damage the heart

At the same time Novartis releases a press release, promoting its drug. There are also side-effects mentioned:


The most common side effects included nausea, superficial edema, muscle cramps, skin rash, vomiting, diarrhea, abdominal pain, myalgia, arthralgia, hemorrhage, fatigue, headache, joint pain, cough, dizziness, dyspepsia and dyspnea, dermatitis, eczema, fluid retention, as well as neutropenia, thrombocytopenia and anemia....

Rare/serious adverse reactions include: sepsis, pneumonia, depression, convulsions, cardiac failure, thrombosis/embolism, ileus, pancreatitis, hepatic failure, exfoliative dermatitis, angioedema, Stevens-Johnson syndrome, renal failure, fluid retention, edema (including brain, eye, pericardium, abdomen and lung), hemorrhage (including brain, eye, kidney and gastrointestinal tract), diverticulitis, gastrointestinal perforation, tumour hemorrhage/necrosis, hip osteonecrosis/avascular necrosis.



So, you can fight cancer with it, but this drug won't make you healthier.....

THURSDAY, Oct. 19 (HealthDay News) -- The breakthrough cancer drug Gleevec will now carry a new "precaution" on its label about possible severe congestive heart failure as a result of its use.

The announcement came Thursday from the U.S.Food and Drug Administration, the same day the drug's maker, Novartis, issued a letter to health-care professionals.

The labeling revision is unlikely to diminish Gleevec's wonder-drug status, experts said.

"You have to remember that people take this drug for what is usually otherwise a fatal condition," said Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society. "Clearly, the benefits of Gleevec for the particular disease it treats far outweigh the risks. What this basically means is that patients have to watch more carefully and be aware of the symptoms, but this does not rise to the level where one would say we should take the drug off the market."

In fact, Lichtenfeld pointed out, the FDA has asked only for a precaution, which is less severe than a warning when it comes to drug labels.

Gleevec (generic name imatinib) is approved to treat chronic myelogenous leukemia -- CML -- and gastrointestinal stromal tumors.

Findings of a study reported at this year's meeting of the American Society of Clinical Oncology reported that overall survival for people with CML who took Gleevec for five years was 89 percent -- and 95 percent if only deaths related to CML were considered. At the same time, 93 percent of the cases still had not progressed from the chronic to the "blast crisis" -- or acute phase -- of the illness.

The label move comes four months after an article in the journal Nature Medicine reported that Gleevec may be toxic to the heart and lead to heart failure. The small study detailed how Gleevec inadvertently targets a protein maintaining cells that contract the heart muscle and help to force blood through the body. This means that other drugs in the same class, tyrosine kinase inhibitors, may also damage the heart, Lichtenfeld said.

"The reality is that they, too, because of the particular way Gleevec causes heart failure problems, are suspect," he said.

The study followed up on 10 patients who developed severe heart failure after taking Gleevec. Those cases were first reported in 2004 by the University of Texas M.D. Anderson Cancer Center in Houston.

According to a letter issued by Novartis and directed to health-care professionals, most of the affected patients had pre-existing conditions such as high blood pressure, diabetes and coronary artery disease.

"The incidence of congestive failure is very small, and many of the patients had other illnesses," Lichtenfeld confirmed.

The letter maintained that "cardiac events remain uncommon" although "severe congestive heart failure and left ventricular dysfunction have occasionally been reported."

Patients with known cardiac disease or risk factors for cardiac failure should be monitored carefully, Novartis stated.

"The only thing this changes is the discussion that you have with the patient when you're talking about starting the medication, and it might also change how you monitor the patient," said Dr. Jonathan Goldberg, a hematology/oncologist at Northern Westchester Hospital in Mt. Kisco, New York. "This medicine works so well for patients with CML that, even though there might be this small risk of heart failure, the benefits still greatly outweigh that risk."

source