A well-known chemotherapy drug prescribed to treat chronic myeloid leukemia (CML) has been allegedly linked through multiple studies to atherosclerosis.

Tasigna atherosclerosis is a condition supposedly brought on by Tasigna, also known generically as nilotinib, which has been on the domestic pharmaceutical market for a little over 10 years.

Tasigna was released by the U.S. Food and Drug Administration (FDA) in 2007 and its on-label use specifically states that it is for the treatment of CML. The Novartis Co. developed and currently manufactures Tasigna with recorded sales close to $2 billion in the year 2016.

What is CML?

According to an online press release by the FDA, the diagnosis of chronic myeloid leukemia (CML) can mean the necessity of remaining on medication for life to keep the disease from worsening or recurring. This is because it is connected to having an abnormal ‘Philadelphia’ chromosome.

CML is considered a bone marrow cancer because the presence of the Philadelphia chromosome causes the body to make an excess of white blood cells. However, it appears Tasigna, the drug prescribed to treat the cancer, has its own complications.

What is Tasigna Atherosclerosis?

Arteries are the blood vessels which supply the cells of the body with oxygenated blood from the lungs. Veins, on the other hand, are the vessels which return blood depleted of oxygen back to the lungs.

Atherosclerosis—a condition in which the interior of the arteries gradually build-up with deposits affecting the ability to transport blood—is commonly known as ‘hardening of the arteries’. The deposits are generally comprised of fatty substances such as cholesterol but can also include calcium and fibrin, a clotting factor in the blood.

Tasigna atherosclerosis has been reported to develop in patients who have used Tasigna for the treatment of CML. Tasigna atherosclerosis allegedly comes on after a certain amount of time on the chemotherapy drug. It can mean that, in addition to the interior plaque build-up, the whole arterial vessel can swell and cut off proper blood flow.

Potentially Severe Consequences of Tasigna Atherosclerosis

Tasigna atherosclerosis can affect several arteries or just one, but the consequences can be dire. Plaque in the arteries of the legs and arms can lead to peripheral artery disease (PAD) and eventually contribute to tissue death and the need for amputations.

Blot clots forming in the arteries can break off and cause cardiac arrest, respiratory arrest, and stroke. Poor circulation can also lead to eventual kidney disease.

In 2011, more than four years after its FDA approval, a study was published with astounding results indicating that at least a quarter of the patients taking Tasigna suffered from some type of vascular disorder or PAD.

In 2013, several other studies came to light with similar conclusions. One of them was a required post-market review by the FDA in which adverse medical event reports were weighed in with other data.

The FDA announced study results in 2013, showing a possible link between Tasigna and atherosclerosis. The agency required information about these findings to be added to the drug’s label.