Tasigna CML treatment is widely used in the patient population, but has been linked to a serious vascular condition called atherosclerosis.

The cancer treatment has been on the market for over a decade, but the alleged correlation with atherosclerosis has only recently gotten more attention.

Tasigna (nilotinib) is a second generation TKI (tyrosine kinase inhibitor) cancer drug, that targets the BCR-ABL protein and is used as a first line treatment for CML (chronic myeloid leukemia). CML cells contain the BCR-ABL protein, which allows cancer to grow and reproduce at a rapid pace. According to the American Cancer Society, Tasigna is regarded as a good choice for this particular form of cancer.

Tasigna has been on the market since 2007, but was released with two “black box” warnings regarding the potential drug side effects. Black box warnings are required for very severe side effects associated with a medical drug or device.

It was not until very recently that atherosclerosis was discovered to be a potential complication for patients undergoing treatment with Tasigna. Over a dozen studies have reportedly linked Tasigna to atherosclerosis, which have been published in prominent medical journals in the United States, Canada, and Europe.

The first study indicating a correlation was published in 2011, which indicated that 25 percent of patients had developed cardiovascular problems and 16 percent of patients developed peripheral arterial disease (PAD) after taking Tasigna. Just two years later in 2013, nine other studies were published that had found similar results.

One of these inquiries was a post market review from the FDA, which analyzed injury reports submitted by patients in the United States, as well as research from Europe and Canada. The FDA stated their findings “strongly [suggested] an association between nilotinib (Tasigna) and PAOD (peripheral arterial occlusive disease.”

Overview of Tasigna and Atherosclerosis Correlation

After these findings were announced, atherosclerosis was added to the drug’s warning label. While this warning helps prevent future cases, it is important for patients undergoing Tasigna CML treatment to understand what atherosclerosis is.

Atherosclerosis is a condition in which the artery walls to thicken and harden due to a buildup of plaque, which complicates circulation. When plaque buildup from atherosclerosis, they could break and cause a blood clot to form.

When blood clots block the artery, it could cause a total loss of circulation. This could lead to difficulties in the legs and may even cause a carotid artery or stroke. If the arteries narrow too much, this condition can potentially evolve into peripheral arterial disease (PAD).

According to the American Heart Association, peripheral artery disease occurs when the peripheral arteries narrow, which pumps blood to the legs, stomach, arms, and head. Due to the nature of this condition, the veins and arteries in the legs are often the most impacted by PAD. The most common PAD symptoms patients experience often consists of cramping, pain, or fatigue in the legs or hip areas, especially when walking up stairs.

Blood clots that remain in the peripheral arteries in the legs can be very painful for patients. The condition can also quickly compound into serious circulation problems including sores, ulcers, gangrene, and even limb amputation.

Overall, Tasigna patients should be vigilant against any signs of circulation problems and should talk to their doctors about any concerns they may have about atherosclerosis. Tasigna patients who developed atherosclerosis may be able to file legal action against Novartis, to seek potential compensation for any pain and suffering they may have suffered from the cancer medication.