Novartis Changes Tasigna's Label But Not Its Toxicity

Some patients can stop taking Tasigna at some point but the drug's long-term side effects such as atherosclerosis will continue

Wednesday, January 16, 2019 - Novartis AG has gone to great lengths to promote the effectiveness of its flagship maker of anti-cancer chemotherapy drug Tasigna. Their marketing efforts of late include petitioning the US Food and Drug Administration (FDA) to allow them to update and thus soften the wording of the Tasigna warning label to include the possibility that some patients that are responding positively to treatment and have their cancer in remission may stop taking treatments. Prior to this change, Tasigna patients were required to continue to use the drug for their entire lifetime. That is still the case in over 95% of Tasigna patients. According to the FDA, "The FDA granted the approval of the Tasigna label changes to Novartis Pharmaceuticals Corporation." If a patient has been taking Tasigna for three or more years they may be eligible to take a test to establish the degree to which treatments have worked. Patients must have "responded to treatment according to specific criteria as detected by a test that has received FDA marketing authorization, may be eligible to stop taking Tasigna." The FDA allowed the company's request to update their product labels to reflect this information. National Tasigna lawyers representing Tasigna cancer patients offer free consultations and information about Tasigna lawsuits.

Unfortunately, as with most Novartis marketing schemes, the updated product label somewhat displaces or lessens the warning patients are given of the severe and life-threatening side effects that Tasigna patients must endure. The reason for Tasigna's effectiveness in killing cancer cells lies in its toxicity, however, this toxicity also immediately destroys the smooth inner lining of the arteries leading to and from the body's vital organs such as the heart, lungs, and brain. When the interior of the artery becomes chaffed the normal, healthy, fatty portion of the blood sticks to the sides of the arterial walls and rapidly accumulates. As the fatty blood hardens it is called plaque and the more plaque that accumulates, the less blood that can flow through the passageway. Eventually, a chunk of plaque will break free and become lodged in the smaller vessels causing a stroke, heart attack or pulmonary thrombosis. The FDA warning on Tasigna states that "Severe side effects of taking Tasigna include myelosuppression, blockages in the heart or arteries (cardiac and arterial vascular occlusive events)." Atherosclerosis should not be underestimated for without undergoing coronary bypass surgery a Tasigna patient's arteries will likely clog to the extent that blood flow will be dangerously restricted. A reduction of blood flow to the extremities of the feet, toes, and fingers can cause necrosis (tissue death) of the toes and feet where the only treatment is amputation.

Doctors prescribing Tasigna are required to monitor their patients for any indication of blood or heart rhythm abnormalities by taking an electrocardiogram (ECG) examination before, during and every month following Tasigna cancer treatments. While Tasigna may be effective in treating certain types of cancer, the risks of developing atherosclerosis-related diseases more than offset its benefits.

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