Tasigna, one of the ten most popular cancer drugs in the world, has been linked to severe and life-threatening side effects. In many cases, patients who have consented to taking Tasigna for treatment of chronic myeloid leukemia were not aware of the risk for rapid-onset atherosclerosis, peripheral arterial disease, and resulting Tasigna complications including tissue death, limb amputation, cardiovascular problems, and death. Causing the arteries to narrow, Tasigna complications are life-threatening and can result in irreversible damage.
Tasigna (generic name nilotinib) is a protein-tyrosine kinase inhibitor and a common treatment option for patients suffering from Philadelphia chromosome-positive chronic myeloid leukemia. A product of Novartis, Tasigna was approved by the FDA in 2007. At that time, the Tasigna warning label did not mention the risk of atherosclerosis or peripheral arterial disease. Tasigna combats leukemia by stopping growth and cell division in cancer cells by preventing the production of a particular chemical enzyme. While Tasigna is relied upon by many oncologists to treat leukemia, safety experts questions whether Tasigna complications outweigh the drug’s benefits.
Tasigna complications include atherosclerosis, which is an arterial condition in which an excess of white blood cells and fibrofatty plaque narrow the arteries (causing peripheral arterial disease). When blood cannot circulate properly through the arteries, various parts of the body may not get the blood flow they require. Inadequate blood flow can result in tissue death and usually affects the legs first. If unchecked, Tasigna atherosclerosis can result in the need for limb amputation and can also lead to coronary artery disease, cardiovascular problems, and even death.
Tasigna atherosclerosis is a cardiovascular condition that can be treated if detected early. Due to the lack of awareness of the risk for atherosclerosis from Tasigna, and the rapid onset of the condition when caused by Tasigna, many patients have suffered from severe and irreversible Tasiga problems.
American patients rely on the FDA to provide up-to-date and thorough warning information about the risks and side effects posed by FDA-approved drugs. In the case of Tasigna atherosclerosis, patients who have filed lawsuits against Novartis say they were not adequately warned. A warning for Tasigna cardiovascular side effects was added to the drug’s warning label in 2013, yet no Tasigna warning information has been promoted to the public in the United States. In comparison, Novartis issued a Tasigna warning statement on atherosclerosis in Canada in 2013, in conjunction with the Canadian health service, allowing Canadian patients to make an informed choice about Tasigna complications.
Novartis has faced Tasigna lawsuits in the past, most notably a 2013 Department of Justice case related to the payment of illegal kickbacks to pharmacies who sold Tasigna instead of a generic alternative. Novartis paid $390 million to the DOJ. The company was also warned by the FDA in 2010 for violating federal regulations related to misbranding and false advertising claims.
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