Tasigna (nilotinib) is one of the primary treatment drugs for chronic myeloid leukemia, but has recently been linked to serious vascular complications. Chronic myeloid leukemia is a rare type of blood cancer, which typically affects adults and progresses over time.

Tasigna works by inhibiting or limiting the reproduction of cancer cells, and is specifically designed to counteract chronic myeloid leukemia cells. Tasigna was approved by the FDA in 2007 and quickly became one of the most popular cancer drugs in the world with Takeda earning $1.7 billion in sales in 2016.

However, over a dozen studies have linked Tasigna with rapid onset atherosclerosis. Atherosclerosis is a condition in which the arteries become clogged, narrow, or harden, which can later evolve into peripheral arterial disease (PAD).

These studies have been published in the United States, Canada, and Europe and found that the medication increased the risk of atherosclerosis and PAD.

The first study was published in 2011, which found 25 percent of patients experienced cardiovascular problems and 16 percent had developed peripheral arterial disease soon after being prescribed the medication for chronic myeloid leukemia treatment.

Just two years later in 2013, nine additional studies were published that all indicated a correlation between Tasigna and atherosclerosis. One of these inquiries was a post market review from the FDA that included reports from the United States, Canada, and Europe.

The FDA stated that the findings had “strongly suggest an association between nilotinib (Tasigna) and PAOD (peripheral arterial occlusive disease).”

Not long after the FDA announced its findings, a warning for atherosclerosis was added to the drug’s warning label. While a Black Box warning was added to Tasigna’s warning label regarding other side effects, patients were not warned about potential atherosclerosis for several years.

Overview of Atherosclerosis and Peripheral Arterial Disease

Atherosclerosis causes artery walls to thicken and harden, potentially leading to the buildup of plaque and increased risk of blood clot complications. If not treated, peripheral arterial disease can cause pain in the arms, legs, and head while doing basic movements. The condition eventually leads to permanent and severe blood flow problems.

If a blood clot forms from atherosclerosis, it can cause serious pain for the patient and can be fatal if not treated. Along with the risk of heart attack and stroke, blood clots can cause loss of circulation in the limbs and may eventually lead to gangrene and limb amputation.

Even though these complications can be devastating for chronic myeloid leukemia patients, who already have a serious medical condition, this information was not disclosed until recently.

Chronic myeloid leukemia patients who were prescribed Tasigna and suffered one or more of the following conditions, may be eligible to file legal action:

• Atherosclerosis
• Peripheral Arterial Disease
• Coronary Artery Disease
• Circulation Issues in Arms, Legs, Heart, or Brain
• Embolic Occlusion
• Heart Attack
• Stroke
• Infection
• Amputation
• Death

Drug manufacturer Novartis is currently facing a growing number of lawsuits alleging they knew of the alleged correlation between Tasigna and atherosclerosis, before it was added to the drug’s warning label.