The FDA May Have Overlooked Tasigna's Atherosclerosis Side Effect When Approving its Usage by Children

Tasigna may be a revolutionary way to treat cancer but may cause other diseases equally bad or worse

Tuesday, February 5, 2019 - The US Food and Drug Administrations recently expanded its approval of anti-cancer chemotherapy drug Tasigna to include treatment of chronic myeloid leukemia in children. Prior to that, the FDA had approved a request from Novartis, maker of Tasigna, to change the Tasigna warning literature. Such a change implies that Tasigna is so effective in fighting chronic myeloid leukemia in adults that patients in remission may actually be able to stop taking the drug, a first in the war against cancer, under the advice of their oncologist. As promising as that may sound, however, one must ask the question "has the FDA overlooked the potentially life-threatening side effects of Tasigna when promoting its usage for babies, children and young adults with cancer?" Given Tasigna's toxicity which promotes atherosclerosis and other heart problems, it seems almost a certainty that a child taking Tasigna will at a very early age develop some form of critical blood abnormality or heart disease from the accumulation of plaque within the major arteries. It is no secret that Tasigna's toxicity has been hidden from the official US health community.

In April of 2013, Tasigna's maker Novartis Pharmaceuticals of Switzerland and Canada's official government health agency, Health Canada, issued a warning to the Canadian cancer community entitled: "TASIGNA (nilotinib) - Possible Risk of Developing Atherosclerosis-Related Conditions." The report stated in no uncertain terms that an unacceptably high number of cancer patients have developed atherosclerosis from taking Tasigna. Now doctors in the US want to give it to children. It is proven that Tasigna irritates the arteries inner walls and causes plaque in the blood to stick to them, accumulate, and narrow the blood's passageway. Lawsuits have been filed against Novartis for failing to warn the cancer community in the US as they did for the people in Canada. Tasigna atherosclerosis lawyers represent persons and families harmed by Tasigna.

To be clear regarding children taking Tasigna, only a specific and very rare form of cancer is included. According to an article in Healio, a hematology and oncology journal, the FDA's opinion to expand the approval of nilotinib is limited to children with chronic Philadelphia chromosome-positive myeloid leukemia "with resistance or intolerance to tyrosine kinase inhibitors" and is based on a study of children with chronic Ph+CML ages 2-18 years old. The study found that 60% of the children given Tasigna produced a "major molecular response " indicating that the disease was heading into remission. Cancer.org defines a major molecular response (MMR) as meaning that "the amount of BCR-ABL gene in your blood is 1/1000th (or less) of what's expected in someone with untreated chronic myeloid leukemia. The BCR-ABL gene "is present in cancer patients with myeloid leukemia, a cancer of the bone marrow and white blood cells. BCR-ABL is found in almost all patients with a type of leukemia called chronic myeloid leukemia (CML). "

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OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The Onder Law Firm has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.