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Tasigna (nilotinib) is a drug manufactured by Novartis to treat chronic myelogenous leukemia (CML). The FDA approved it for this use in 2007, but since then, there have been several studies that have linked the medication with an increased risk for atherosclerosis. In 2013, Health Canada issued a public communication warning patients and doctors that cases of atherosclerosis-related conditions had been reported during clinical trials and post-marketing experience with the use of Tasigna. Patients who have been injured by this drug may be eligible to file a Tasigna lawsuit.

What is Chronic Myelogenous Leukemia (CML)?

CML is a type of slow-growing cancer that affects the bone marrow and blood cells. It occurs because of a gene mutation called the “Philadelphia chromosome.”  This abnormal chromosome causes the bone marrow to produce an abnormal enzyme (the BCR-ABL tyrosine kinase), which stimulates the abnormal CML white blood cells to grow out of control.

Over time, the bone marrow produces too many of the abnormal white blood cells. As more and more of these abnormal cells develop, they crowd out the healthy blood cells and damage the bone marrow.  Symptoms of CML may include fatigue, fever, loss of appetite, night sweats, easy bleeding, and pain or fullness on the left side.  Many people with CML, however, do not have symptoms when it is diagnosed.

Novartis Replaces Gleevec with Tasigna

The goal of CML treatment is to eliminate the abnormal blood cells that contain the BCR-ABL protein. Tasigna (nilotinib) is one of several drugs that can do this. It focuses on blocking the action of tyrosine kinase.  It is usually reserved for those patients who have tried other medications initially that did not work.

Novartis developed Tasigna to replace their other CML drug, Gleevec. Gleevec had performed well for the company, but the patent expired in 2015.  Once it became available as a generic drug, Novartis earned less from its sale.

According to the Novartis website, Tasigna was shown to be more effective than Gleevec in clinical trials.

Tasigna Label Fails to Warn About Atherosclerosis

Tasigna, like any drug, has potential side effects. These include abdominal pain, fatigue, nausea, joint pain, and constipation.  One potential side effect that’s not listed on the label, however, is atherosclerosis.

Atherosclerosis is an artery disease can lead to a heart attack, stroke, peripheral artery disease, or even death. According to a 2016 study, it is the leading cause of vascular disease worldwide.  Atherosclerosis occurs when there is a gradual plaque buildup in the arteries.  Over time, it becomes more difficult for the heart to pump blood through the narrowed, hardened arteries.

A number of studies have shown that Tasigna can increase risk of atherosclerosis. In 2011, for example, researchers linked the drug to peripheral artery disease and sudden death.  In 2013, researchers reported that Tasigna (nilotinib) was associated with higher rates of arterial disease than imatinib, another similar drug.

In a letter to the editor published in the scientific journal Leukemia, Mayo Clinic Doctor Ayalew Tefferi referred to several other studies linking Tasigna to atherosclerosis, heart attack, peripheral artery disease, coronary artery disease, and other related conditions.  He concluded, “[t]aken together, the above observations strongly implicate [Tasigna] therapy as being proatherogenic.”  Dr. Tefferi recommended that doctors should consider using other medications instead of Tasigna.

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