The FDA May Be Putting Children's Lives In Danger By Ignoring Tasigna's Atherosclerosis Risk

The FDA is rolling the dice when one adds the already high rates of atherosclerosis in children given anti-cancer drugs with Tasigna's admission of being the most toxic drug of them all

Tuesday, February 12, 2019 - In spite of documentary films showing the FDA to be too lax in requiring thorough and thoughtful pre-market human testing of drugs before they are offered to the public, the expanded use of dangerous drugs is now happening for treating children with cancer. The FDA recently approved Tasigna, a dangerous yet highly effective anti-cancer drug for use in certain cases of children with childhood cancers. According to Tasigna's maker, Novartis AG, "Tasigna is approved in the United States (US) for the treatment of Ph+ CML in the chronic phase in pediatric patients one year of age or older with resistance or intolerance to prior therapy including imatinib and for the treatment of pediatric patients one year of age or older with newly diagnosed Ph+ CML."

In approving Tasigna's use for children, the FDA appears to be ignoring warnings that Tasigna is so toxic that it causes atherosclerosis in otherwise healthy adults with cancer. The FDA is all but ignoring the findings from as early as 2008 and documented in Cure Today (Cancer Updates, Research, and Education) that shows children surviving cancer have as high as a 10-fold chance of developing atherosclerosis. Those findings were presented to the American Society of Clinical Oncology in Chicago where scientists showed concern that nothing was being done to address the atherosclerosis risks. The studies analyzed 14,000 childhood cancer survivors under 21 years old, and found a "10 times greater risk for atherosclerosis (hardening of the arteries); 5.7 times greater risk for congestive heart failure; 4.9 times greater risk for myocardial infarction (heart attack); 6.3 times greater risk for pericardial disease and 4.8 times greater risk for valvular disease."

What makes the FDA's decision even more dubious is that Novartis has previously warned the Canadian government about Tasigna causing atherosclerosis. Doctors and the Canadian cancer community were warned in 2013 that "Cases of atherosclerosis-related conditions have been reported during clinical trials and post-marketing experience with the use of TASIGNA." No such atherosclerosis warning of Tasigna's atherosclerosis has ever made it to the US.

Atherosclerosis causes the arteries to become clogged by the buildup of fatty tissue called plaque. When plaque accumulates the arteries become more narrow reducing the flow of oxygen and nutrient-rich blood to the extremities. As the plaque hardens it can become dislodged by physical exertion and high blood pressure, causing a blockage in the smaller arteries leading to the brain and heart.

Children given Tasigna should be monitored before, during and for months after Tasigna treatments start for the earliest sign of atherosclerosis such as extreme weakness and tiredness alerting them that not enough nutrient-rich blood is getting to the legs and feet. Also, numbness, tingling or pain in the toes and feet could indicate that atherosclerosis may be developing.

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