Drug manufacturers may not have warned the public about the cardiovascular side effects of Tasigna including atherosclerosis.

Tasigna (nilotinib) is a twice daily cancer drug in pill form that is used in the treatment of recently diagnosed Philadelphia chromosome positive chronic myeloid leukemia (CML), a type of cancer that causes the body to make too many abnormal white blood cells. The drug is part of the antineoplastic drug class and interferes with the growth of cancer cells to treat the disease.

Like many cancer treatments, notes the Mayo Clinic, Tasigna carries the risk of damaging healthy cells in the body which can cause a variety of side effects.

According to the National CML Society, side effects of Tasigna may include too few white blood cells or platelets, changes in liver enzymes, changes in pancreatic enzymes, nausea, constipation, diarrhea, itching, and a rash. The drug also carries a black box warning, which is the strongest warning placed by the U.S. Food and Drug Administration (FDA), for the risk of elongating part of the heart’s rhythm.

Additionally, studies have revealed that side effects of Tasigna may include atherosclerosis – a condition which involves the thickening and hardening of arterial walls due to plaque buildup. Atherosclerosis can lead to the narrowing of arteries which may in turn cause peripheral arterial disease and circulation problems.

The hard plaque buildup associated with atherosclerosis can be especially dangerous if it becomes inflamed or brittle which can lead to part of the plaque breaking off and triggering a blood clot. This blood clot can cause the artery to become even narrower or completely blocked.

Blocked arteries can lead to a variety of complications including circulatory problems which may be permanent. If these blockages compromise blood flow to the legs or feet, gangrene and limb amputation is a possible outcome. If blockages occur in a carotid artery, it can lead to a stroke.

Tasigna was first linked to the complicated cardiovascular condition in a 2011 study. This study found that 25 percent of patients treated with the drug experienced vascular problems and 16 percent suffered from peripheral arterial disease.

In 2013, nine more Tasigna atherosclerosis studies investigating the link were published. One study was an FDA postmarket review looking at adverse event reports from the United States, Canada, and Europe. The review concluded that findings “strongly suggest an association between nilotinib (Tasigna) and PAOD (peripheral arterial occlusive disease).” After this conclusion, a warning for Tasigna atherosclerosis was added to the drug’s label.

Some consumers have taken legal action against Novartis, Tasigna’s manufacturer, claiming that the company knew about the risk for atherosclerosis for years and did not warn consumers. Instead, Novartis allegedly launched an aggressive advertising campaign that made Tasigna seem superior to other cancer treatments.

Plaintiffs in Tasigna atherosclerosis lawsuits argue that they were not sufficiently warned about the risk for vascular complications on the cancer drug, meaning they were unable to make an informed treatment plan with their doctor that considered all of the risks at play.